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# Facet Life Sciences

Development Solutions for Small Teams with Big Goals

## Sitemaps

- [XML Sitemap](https://facetlifesciences.com/sitemap.xml): Contains all public & indexable URLs for this website.

## Posts

- [Blog & Insights](https://facetlifesciences.com/blog/) - Expert insights on regulatory strategy, product development, and commercialization tactics for emerging biotech, pharma, and device companies.
- [How Do I Determine Good Regulatory Guidance?](https://facetlifesciences.com/2025/07/28/regulatory-guidance/) - Learn how to evaluate FDA regulatory guidance, avoid common pitfalls, and align strategy with business goals.
- [Facet Life Sciences and XCancer Announce Strategic Partnership to Advance Theranostic Clinical Trials](https://facetlifesciences.com/2025/11/06/facet-life-sciences-and-xcancer-announce-strategic-partnership-to-advance-theranostic-clinical-trials/) - Facet Life Sciences, a leader in regulatory strategy and drug development services, today announced a strategic partnership with XCancer®, a global leader in theranostic clinical research, to accelerate the development and approval of next-generation radiopharmaceutical therapies in oncology.
- [New Services: Strategic Statistical Support](https://facetlifesciences.com/2024/02/13/new-services-strategic-statistical-support/) - Facet’s new Strategic Statistical Services group uses statistical principles and methodologies to maximize precision and efficiency in the development of drugs, biologics, medical devices, and combination products. More and more, small organizations are learning the value of statistics to strategically accomplish corporate and development goals more quickly and efficiently. To help our clients leverage every
- [Facet Life Sciences Evolves Leadership Structure to Strengthen Product Pathmaking Solutions & Deepen Partnership Value](https://facetlifesciences.com/2026/05/12/facet-life-sciences-evolves-leadership-structure-to-strengthen-product-pathmaking-solutions-deepen-partnership-value/) - Facet Life Sciences, a leader in regulatory strategy and drug development services, today announced a strategic partnership with XCancer®, a global leader in theranostic clinical research, to accelerate the development and approval of next-generation radiopharmaceutical therapies in oncology.
- [Facet Life Sciences Appoints Frank A. Closurdo as VP, Commercial Services, Strengthening Integrated Regulatory and Market Guidance](https://facetlifesciences.com/2026/06/01/facet-life-sciences-appoints-frank-a-closurdo-as-vp-commercial-services-strengthening-integrated-regulatory-and-market-guidance/) - Facet Life Sciences, a leader in regulatory strategy and drug development services, today announced a strategic partnership with XCancer®, a global leader in theranostic clinical research, to accelerate the development and approval of next-generation radiopharmaceutical therapies in oncology.
- [Sometimes a Second Opinion Is Worth Millions](https://facetlifesciences.com/2026/06/29/sometimes-a-second-opinion-is-worth-millions/) - Emerging biotechs need a different FDA playbook. Facet makes the case in a new Life Sciences Review article.
- [Facet Life Sciences Named Regulatory Partner for Cybin’s Neuropsychiatry Therapeutics Development Pipeline](https://facetlifesciences.com/2024/12/04/facet-life-sciences-named-regulatory-partner-for-cybins-neuropsychiatry-therapeutics-development-pipeline/) - Facet Life Sciences, a leader in US regulatory strategy and product development solutions for the life sciences industry, has been named as the US regulatory partner for Cybin Inc. (“Cybin”), a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative treatment options to address the large unmet need for people
- [Facet's Dana Blue Returns to AMWA Regulatory Writing Subcommittee for 2026](https://facetlifesciences.com/2026/04/15/facets-dana-blue-returns-to-amwa-regulatory-writing-subcommittee-for-2026/) - Facet Life Sciences' Dana Blue rejoins the AMWA Regulatory Writing Subcommittee, helping shape worldwide training programs for the 4th consecutive year.
- [FDA Nonclinical Requirements for Radiopharmaceutical Drugs: Diagnostic vs. Therapeutic Pathways](https://facetlifesciences.com/2025/07/02/radiopharmaceuticals/) - A simplified nonclinical path is possible for radiopharmaceuticals. But what FDA requires depends on program type and key development features.
- [Facet Life Sciences Recognized in Top 10 Regulatory Services Companies for 2023](https://facetlifesciences.com/2023/02/08/facet-life-sciences-recognized-in-top-10-regulatory-services-companies-for-2023/) - Facet Life Sciences, a leading provider of regulatory strategy and consulting services, has been recognized as one of the top ten regulatory companies for 2023 by Life Sciences Review. We work with clients to understand the unique nature of their drug, biologic, device, gene therapy, or combination product to develop the most efficient, scientifically sound,
- [Facet Life Sciences Quarterly Update Q1 - 2023](https://facetlifesciences.com/2023/04/17/facet-life-sciences-quarterly-update-q1-2023/) - Explore Facet Life Sciences' Q1 2023 quarterly update, highlighting key achievements, industry insights, and strategic developments in life sciences.
- [Events - SNMMI 2023 Therapeutics Conference](https://facetlifesciences.com/2023/09/11/events-snmmi-2023-therapeutics-conference/) - Discover the latest in therapeutic advancements with Facet Life Sciences at the SNMMI 2023 Conference. Connect with experts and industry pioneers.
- [Events - AusBiotech Conference 2023](https://facetlifesciences.com/2023/09/11/events-ausbiotech-conference-2023/) - Join Facet Life Sciences at the AusBiotech Conference 2023. Engage with the industry leaders and explore innovations in biotechnology.
- [Facet Life Sciences Recognizes Michelle Byrne's Achievements](https://facetlifesciences.com/2023/09/28/facet-life-sciences-recognizes-michelle-byrnes-achievements/) - Congratulations to Michelle Byrne! Michelle has just been awarded her RAC. We’re so proud of her achievement. Regulatory Affairs Certification (RAC), is the only post-academic professional credential for regulatory professionals in the healthcare product sector. It is intended for individuals employed in regulatory agencies, industry, consultancies and other settings involved with the regulation of healthcare products.
- [Facet Life Sciences Quarterly Update Q3 - 2023](https://facetlifesciences.com/2023/10/27/facet-life-sciences-quarterly-update-q3-2023/) - Read Facet Life Sciences' Q3 2023 quarterly update, featuring crucial progress, emerging opportunities, and analysis of the life sciences industry.
- [FDA Round Up - Q3 2023](https://facetlifesciences.com/2023/10/27/fda-round-up-q3-2023/) - Catch up on pivotal FDA updates and analyses from Q3 2023. Facet Life Sciences delivers crucial regulatory information for industry leaders.
- [Partner News - Q3 2023](https://facetlifesciences.com/2023/10/27/partner-news-q3-2023/) - Learn about our successful collaborations and partnerships in Q3 2023. Facet Life Sciences fosters impactful alliances in the life sciences sector.
- [Facet Life Sciences Recognizes Dr. Jason Mercer's Achievements](https://facetlifesciences.com/2024/01/08/facet-life-sciences-recognizes-dr-jason-mercers-achievements/) - Congratulations to Dr. Jason Mercer ! Dr. Jason Mercer has been chosen to serve as a committee member on the Food and Drug Law Institute's (FDLI) Medical Products committee this year. As part of the committee, Dr. Mercer will assist in identifying medical product topics for programming and in sharing important developments in the field. FDLI
- [From The Corner Office](https://facetlifesciences.com/2024/02/13/from-the-corner-office/) - Ken VanLuvanee, President & CEO It was a wonderful 2023 for the team at Facet Life Sciences. We had some fun, welcomed several new team members into the Facet family, joined hands with several new clients, and advanced some awesome science. We even collected a few recognitions along the way. As we have each
- [Spotlight On - Q4 2023](https://facetlifesciences.com/2024/02/13/spotlight-on-q4-2023/) - Discover key projects and achievements from Q4 2023 with Facet Life Sciences, showcasing impactful collaborations and innovation.
- [Facet By The Numbers - Q4 2023](https://facetlifesciences.com/2024/02/13/facet-by-the-numbers-q4-2023/) - Review Facet Life Sciences’ achievements and progress from Q4 2023, highlighting our commitment to regulatory success.
- [New Services: Strategic Commercialization Support](https://facetlifesciences.com/2024/02/13/new-services-strategic-commercialization-support/) - In February, Facet will be launching a Strategic Commercialization Services group that helps organizations understand and build health economics, market access, product launch, and reimbursement planning into their product development. Our commercialization experts will help Sponsors select the ideal indications for their products, design the right clinical trials with endpoints that will support ideal, competitive
- [Facet Life Sciences Recognized in Top 10 Regulatory Services Companies for 2024](https://facetlifesciences.com/2024/02/14/facet-life-sciences-recognized-in-top-10-regulatory-services-companies-for-2024/) - Facet Life Sciences earns a spot in the Top 10 Regulatory Services Companies for 2024, celebrating excellence in regulatory consulting.
- [Facet Life Sciences Quarterly Update Q1 - 2024](https://facetlifesciences.com/2024/04/16/facet-life-sciences-quarterly-update-q1-2024/) - Examine Facet Life Sciences' Q1 2024 quarterly update, presenting vital insights, growth metrics, and breakthroughs driving life sciences forward.
- [Spotlight On - Q1 2024](https://facetlifesciences.com/2024/04/16/spotlight-on-q1-2024/) - Highlighting successful projects and collaborations from Q1 2024, Facet Life Sciences continues to drive regulatory innovation and success.
- [Industry Focus - Q1 2024](https://facetlifesciences.com/2024/04/16/industry-focus-q1-2024/) - Explore key industry trends and focus areas for Q1 2024 with Facet Life Sciences, offering valuable insights and analysis.
- [Go Team! - Q1 2024](https://facetlifesciences.com/2024/04/16/go-team-q1-2024/) - Celebrate the accomplishments of Facet Life Sciences' team in Q1 2024, recognizing their dedication and collaborative spirit.
- [Spotlight On Rare Disease Development - Q1 2024](https://facetlifesciences.com/2024/04/16/spotlight-on-rare-disease-development-q1-2024/) - Discover Facet Life Sciences' advancements in rare disease development during Q1 2024, showcasing innovative projects and strategic progress.
- [Did You Know - Q1 2024](https://facetlifesciences.com/2024/04/16/did-you-know-q1-2024/) - Stay informed with Facet Life Sciences' 'Did You Know' insights for Q1 2024, presenting key trends and industry updates.
- [FDA Round Up - Q1 2024](https://facetlifesciences.com/2024/04/16/fda-round-up-q1-2024/) - Get the latest FDA updates and insights from Q1 2024 with Facet Life Sciences, providing critical information for industry stakeholders.
- [Facet By The Numbers - Q1 2024](https://facetlifesciences.com/2024/04/16/facet-by-the-numbers-q1-2024/) - Review Facet Life Sciences' Q1 2024 performance highlights and milestones, underlining our commitment to regulatory achievements.
- [Industry Focus Q2-2024: Chevron Deference](https://facetlifesciences.com/2024/08/29/industry-focus-q2-2024-1/) - Supreme Court Overrules Chevron Deference; What Now? June 28, in a case known as Loperbright Enterprises v. Raimondo (Loperbright), the United States Supreme Court overturned a 40-year-old precedent known as Chevron deference. This precedent favored federal agencies’ interpretations of statutes that provided authority for agency rulemaking. After the Loperbright decision, courts will no longer be
- [Industry Focus Q2 2024 - FDA Final Guidance for Lab Developed Tests](https://facetlifesciences.com/2024/08/29/industry-focus-q2-2024-2/) - Industry Focus: FDA Final Guidance for Laboratory Developed Tests FDA Issues Small Entity Compliance Guide When they originated in 1976, laboratory developed tests (LDTs) were manufactured and used locally for unique or regional pathologies. Today, many LDTs are run in diverse populations and batched in high volumes outside of the patient healthcare setting, are used
- [Industry Focus Q2-2024: Chinese and Indian Biotech Update](https://facetlifesciences.com/2024/09/03/industry-focus-q2-2024-3/) - Update on Chinese and Indian Biotech In the Spotlight As we reported in our last newsletter (here), ex-US CDMOs and CROs (especially those in China) have been the subject of US political and growing biopharma industry scrutiny. On June 18, 2024, FDA publicly announced that Sponsors who used Synapse Labs Pvt. Ltd. (a CRO
- [Spotlight On Rare Disease Development - Q2 2024 - New RD Hub](https://facetlifesciences.com/2024/09/03/spotlight-on-rare-disease-development-q2-2024-1/) - New RD Hub On July 17, 2024, the FDA announced that they are establishing a Rare Disease Innovation Hub (the Hub). The Hub will work with all rare diseases, but will “focus on products intended for smaller populations or for diseases where the natural history is variable and not fully understood.” This focus is particularly
- [Spotlight On Rare Disease Development - Q2 2024 - START Pilot Program Updates](https://facetlifesciences.com/2024/09/03/spotlight-on-rare-disease-development-q2-2024-2/) - START Pilot Program Updates In our 4Q2023 newsletter, we reported on FDA’s Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program. This program is designed to help facilitate more efficient development of potentially life-saving therapies for rare diseases and to help Sponsors generate high-quality data to support future NDA/BLA applications. FDA recently published
- [ICYMI - Q2 2024 - PET CMC Coalition](https://facetlifesciences.com/2024/09/03/icymi-q2-2024-1/) - Facet Joins PET CMC Coalition In May, Facet joined the Coalition of PET Drug Manufacturers, a not-for-profit organization that seeks to help PET drug manufacturers to gain and maintain US marketing authorizations for PET drugs and comply with good manufacturing practice regulations (21 CFR Part 212). We are delighted to be active participants in this
- [ICYMI - Q2 2024 - FDLI Annual Conference](https://facetlifesciences.com/2024/09/03/icymi-q2-2024-2-fdli-annual-conference/) - Facet Attends the Food and Drug Law Institute (FDLI) Annual Conference In May, Dr. Jason Mercer attended the Food and Drug Law Institute (FDLI) Annual Conference. FDLI brings together legal and regulatory professionals that work within FDA regulated industries. We are excited to attend this conference to hear from and interact with FDA staff, the
- [ICYMI - Q2 2024 - Market Access Society of America Symposium](https://facetlifesciences.com/2024/09/03/icymi-q2-2024-3-ma-symposium/) - Facet Attends the Market Access Society of America Symposium Dr. Randy Goodman attended the May 21st Market Access Society of America Symposium. This global conference brings together government and industry experts, researchers, and consultants with the goal of educating and shaping the future of market access. From a broad perspective, the phrase “market access” (MA)
- [ICYMI - Q2 2024 - Psychedelic Therapeutics & Drug Development Conference](https://facetlifesciences.com/2024/09/03/icymi-q2-2024-4-psychedelic-conference/) - Facet Attends Psychedelic Therapeutics & Drug Development Conference In May, Dr. Jason Mercer attended the Psychedelic Therapeutics & Drug Development Conference. This conference brought together academic and industry experts in the field of psychedelic therapeutics. Conference presentations included discussions of early stage psychedelic therapeutic products, research into the mechanisms of action of psychedelic therapeutics in
- [ICYMI - Q2 2024 - SNMMI](https://facetlifesciences.com/2024/09/03/icymi-q2-2024-5-snmmi/) - Facet Attends SNMMI In June, Dr. Lisa Jenkins VanLuvanee attended the Society of Nuclear Medicine & Molecular Imaging (SNMMI) annual meeting. SNMMI is an educational, scientific, research, and networking organization focused on providing physicians, technologists, pharmacists, laboratory professionals, and scientists with cutting edge information on the latest diagnostic imaging and theragnostic research and practical applications.
- [ICYMI - Q2 2024 - SNMMI's Mars Shot](https://facetlifesciences.com/2024/09/03/icymi-q2-2024-6-mars-shot/) - Facet Donates to SNMMI’s Mars Shot Facet is proud to be a SNMMI Mars Shot Research Fund donor in 2024. The goal of this fund is to improve and extend the lives of patients with cancer through innovation with radiopharmaceuticals. Their concept, “By funding high-risk research, Mars Shot seeks to push the boundaries of science,
- [Go Team! - Q2 2024](https://facetlifesciences.com/2024/09/03/go-team-q2-2024/) - Team Focus – New Facet Team Members We are excited to announce the addition of 3 new team members. Eva Raspor, Strategic Regulatory Writer Facet welcomes Eva Raspor to our team as a Strategic Regulatory Writer. Eva has a wealth of experience related to writing for multiple projects, indications, and applications. Prior to joining Facet,
- [Facet By The Numbers - Q2 2024](https://facetlifesciences.com/2024/09/03/facet-by-the-numbers-q2-2024/) - FACET BY THE NUMBERS Total ESG submissions to FDA Apr – June 2024: Over 30! Early-Stage Development Highlights 6 formal FDA meetings, 1 investigator-initiated IND, over 25 IND amendments (e.g., new protocols/amendments, CMC updates, nonclinical study reports, information amendments, IND annual reports, orphan designation annual reports, safety reporting/DSURs); prepared several gap analyses and regulatory development
- [Facet Life Sciences Quarterly Update Q2 - 2024](https://facetlifesciences.com/2024/09/03/facet-life-sciences-quarterly-update-q2-2024/) - Examine Facet Life Sciences' Q1 2024 quarterly update, presenting vital insights, growth metrics, and breakthroughs driving life sciences forward.
- [Facet Life Sciences Announces Partnership with Nucleus as Official Regulatory Partner](https://facetlifesciences.com/2025/05/29/facet-life-sciences-announces-partnership-with-nucleus-as-official-regulatory-partner/) - Facet Life Sciences partners with Nucleus to provide expert FDA regulatory support for radiopharmaceuticals. Learn more.
- [Facet is Proud to be a 2025 SNMMI Mars Shot Research Fund Donor](https://facetlifesciences.com/2025/06/10/mars-shot/) - Facet’s donation to the 2025 Mars Shot initiative will help to use molecular imaging to accelerate key advancements in medicine.
- [Target Product Profile for Emerging Biotech: Strategic Asset or Expensive Distraction?](https://facetlifesciences.com/2026/05/15/target-product-profile-for-emerging-biotech/) - What every emerging biotech needs to know about a TPP: when to use it, when to avoid it, and smarter alternatives for early-stage drug and device development.
- [The Role of a Statistician in FDA Meetings (and Why It Matters)](https://facetlifesciences.com/2025/07/28/strategic-statistical-consulting/) - FDA reviewers don’t just evaluate your results. They evaluate how you got them. See how a strategic statistician consultant shapes the regulatory conversation.
- [Why Separating Regulatory and Commercial Strategy Can Kill an Otherwise Promising Biotech](https://facetlifesciences.com/2026/04/15/why-separating-regulatory-and-commercial-strategy-can-kill-an-otherwise-promising-biotech/) - Why separating regulatory strategy & commercial strategy can kill an otherwise promising biotech–and how to do it differently.
- [Behind the Scenes of a Productive Nonclinical Type C Meeting Strategy](https://facetlifesciences.com/2026/04/15/behind-the-scenes-of-a-productive-nonclinical-type-c-meeting-strategy/) - See how a Type C meeting strategy allowed a small pharma company to align nonclinical development for a rare pediatric gene therapy with FDA expectations.
- [Leveraging Breakthrough Therapy Designation (BTD) for Gene Therapy Development](https://facetlifesciences.com/2026/04/15/leveraging-breakthrough-therapy-designation-btd-for-gene-therapy-development/) - Successfully navigating the FDA breakthrough designation application process and maximizing BTD value.
- [Why Do You Need a Life Sciences Product Landscape Assessment?](https://facetlifesciences.com/2024/11/08/why-do-you-need-a-life-sciences-product-landscape-assessment/) - Uncover market insights with a life sciences landscape assessment. Identify unmet needs, assess competitors, and make informed, strategic product decisions.
- [PDUFA User Fees- Impact On Your Submission](https://facetlifesciences.com/2016/12/04/pdufa-user-fees-impact-on-your-submission/) - PDUFA USER FEES – IMPACT ON YOUR SUBMISSION The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 to allow FDA to organize and hire staff with the ultimate desired result of decreased time to an action on the marketing application. Each sponsor of a New Drug Application (NDA) or Biologics License Application (BLA)
- [Leveraging Development Opportunities in Radiopharmaceuticals](https://facetlifesciences.com/2025/12/19/leveraging-development-opportunities-in-radiopharmaceuticals/) - Leverage development opportunities with insights on radiopharmaceuticals market trends, U.S. payer expectations, and commercialization strategy.
- [Understanding the Different Types of Gap Analysis in Life Sciences](https://facetlifesciences.com/2025/09/23/types-of-gap-analysis/) - Discover the types of gap analysis in life sciences and how Facet Life Sciences can help address regulatory, clinical, and development gaps.
- [Importance of Asset Valuation in Pharmaceutical Research and Development](https://facetlifesciences.com/2025/09/10/early-stage-valuation/) - Learn how Facet guides pharmaceutical research and development with R&D asset valuation, early stage valuation, and evidence-based planning.
- [Identifying and Closing Gaps Before NDA Filing](https://facetlifesciences.com/2025/08/28/nda-gap-analysis/) - Conduct an NDA gap analysis to spot and resolve issues before filing an NDA with FDA. Reduce delays and improve your chances of approval.
- [Behind the Scenes of an FDA Type C Meeting: A Case Study in Using Gap Analysis to Align Nonclinical Strategy in a Rare Pediatric Disease](https://facetlifesciences.com/2025/08/07/fda-type-c-meeting/) - Discover how a gap analysis and an FDA Type C meeting can streamline your nonclinical strategy and lead to FDA meeting success.
- [Navigating the CMC Journey in Radiopharmaceuticals](https://facetlifesciences.com/2025/08/12/radiopharmaceuticals-2/) - Discover the CMC challenges and strategies from the "Tinker to Treasure" webinar for companies navigating radiopharmaceuticals and regulatory requirements.
- [Expanded Access & Compassionate Use: FDA Guidelines & Key Facts](https://facetlifesciences.com/2025/03/07/expanded-access-compassionate-use-fda-guidelines-key-facts/) - Discover how Expanded Access and Compassionate Use works, FDA requirements, & the benefits & challenges of providing investigational treatments to patients.
- [Navigating the FDA’s Draft Guidance on Developing Cellular and Gene Therapy (CGT) Products](https://facetlifesciences.com/2025/02/21/cellular-and-gene-therapy/) - Navigate FDA guidance for CGT products. Learn key steps for approval and compliance. Get expert help from Facet Life Sciences.
- [Understanding Type B FDA Meetings](https://facetlifesciences.com/2025/03/08/type-b-fda-meetings/) - Discover key strategies for navigating Type B FDA meetings, ensuring your meeting materials are well-prepared and improve your probability of success.
- [Understanding Type C FDA Meetings: A Flexible Forum for Regulatory Guidance](https://facetlifesciences.com/2025/03/09/type-c-fda-meetings/) - Maximize your FDA Type C meeting by engaging early, addressing regulatory challenges, and ensuring a smoother drug development process with expert strategies.
- [FDA Type D Meetings: A New Option for Targeted, Time-Sensitive Regulatory Guidance](https://facetlifesciences.com/2025/03/10/fda-type-d-meetings/) - Discover key strategies and insights for sponsors navigating Type D meeting with the FDA. Enhance your preparation and ensure successful engagement.
- [Understanding FDA Type A Meetings: Purpose, Process, and Key Considerations](https://facetlifesciences.com/2025/03/11/fda-type-a-meeting/) - FDA Type A meetings help resolve clinical holds and disputes in drug development. Discover the process, timeline, and key considerations for sponsors.
- [Navigating the Pre-BLA Meeting Process: Securing a Clear Pathway to Success](https://facetlifesciences.com/2025/03/17/pre-bla-meeting-process/) - Learn how to request and prepare for a Pre-BLA meeting with FDA. Discover how to define success and secure a clear pathway forward for your BLA.
- [Navigating Pre-IND Meetings: A Strategic Guide](https://facetlifesciences.com/2025/03/22/pre-ind-meetings/) - Learn how to request a Pre-IND meeting with FDA, prepare an effective background package, and define success by gaining a clear path forward.
- [Three Key Considerations for Navigating FDA Oversight in Radiopharmaceutical Product Development](https://facetlifesciences.com/2025/08/13/radiopharmaceutical/) - Navigate key challenges in radiopharmaceutical product development under FDA oversight. Get guidance with insightsfrom the experts at Facet Life Sciences.
- [Everyone is Talking About HEOR! What Exactly is it and Why is it Relevant to You?](https://facetlifesciences.com/2025/07/24/heor/) - Explore expert insights on HEOR and how its 8 essential components support cost-efficient, evidence-driven strategies across every stage of R&D.
- [Leveraging Breakthrough Therapy Designation (BTD) for Gene Therapy Development: Key Lessons from a Case Study](https://facetlifesciences.com/2025/07/07/breakthrough-therapy-designation/) - Discover expert insights from Facet to maximize Breakthrough Therapy Designation, accelerate therapy development and navigate FDA approval with confidence.
- [Key Challenges with Orphan Drug Development for Rare Disease Treatments](https://facetlifesciences.com/2025/06/17/orphan-drug-development/) - Explore the unique hurdles developers face with orphan drug development when creating treatments for rare diseases and how to overcome these challenges.
- [Understanding the Impact of the 2025 CPT Code Updates on Healthcare Innovation](https://facetlifesciences.com/2024/12/10/understanding-the-impact-of-the-2025-cpt-code-updates-on-healthcare-innovation/) - By Randy Goodman, Ph.D., MHA, FACHE, PMP, BCMAS The American Medical Association (AMA) has officially released the updated Current Procedural Terminology (CPT) codes for 2025. This release marks a significant update reflecting the rapid advancements in medical technology and innovative healthcare practices. Why the 2025 CPT Code Set Matters to Your Business The CPT code
- [What are the Different FDA Meeting Types for Drugs and Biologics?](https://facetlifesciences.com/2025/03/07/what-are-the-different-fda-meeting-types-for-drugs-and-biologics/) - Discover the different FDA meeting types and gain essential insights for effective engagement to enhance your preparation strategies.
- [New FDA Guidance: Control of Nitrosamine Impurities in Human Drugs (September 2024)](https://facetlifesciences.com/2024/10/21/new-fda-guidance-control-of-nitrosamine-impurities-in-human-drugs-september-2024/) - FDA issued Revision 2 of the guidance for industry Control of Nitrosamine Impurities in Human Drugs. As a class of compounds, nitrosamines are potent genotoxins both in vitro and in several animal species. Some nitrosamines are listed as probable or possible human carcinogens by the International Agency for Research on Cancer (IARC) (1). Nitrosamine formation
- [Facet Life Sciences Certified as Best Places to Work for 2023](https://facetlifesciences.com/2023/06/17/facet-life-sciences-certified-as-best-places-to-work-for-2023/) - Facet Life Sciences is excited to announce that we are now Great Places to Work Certified! This is an honor given to us by our employees and we couldn’t be prouder. 100% of employees at Facet Life Sciences say it is a great place to work compared to 57% of employees at a typical U.S.-based company. Facet’s commitment to helping small,
- [Orphan Drug Development-Challenges and Incentives](https://facetlifesciences.com/2016/12/04/orphan-drug-development-challenges-and-incentives/) - Many of the small pharma companies that VRS supports are developing drugs for rare diseases and conditions. Development of orphan drug (or biologic) products is important to the medical community. “Many diseases appear early in life, and a total of 30 percent of children with orphan diseases die before the age of five. Global
- [Electronic Requirement, Are You Ready?](https://facetlifesciences.com/2016/12/04/electronic-requirement-are-you-ready/) - The Food and Drug Administration Safety and Innovation Act (FDASIA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that certain submissions under the FD&C Act and the Public Health Service Act be submitted in electronic format specified by FDA. On May 15, 2015, FDA published the final “Guidance on Providing Regulatory
- [The Future of Post-Approval Change Management](https://facetlifesciences.com/2016/12/05/the-future-of-post-approval-change-management/) - Reproduced with permission from DIA North America. You can see the original here. By Sarah DeMare, Facet Life Sciences Quality by Design (QbD) was introduced nearly ten years ago as part of FDA’s 21st century quality initiative. The ultimate goal is to reach the desired state of quality defined by Janet Woodcock as “a maximally
- [Virtual Regulatory Solutions Rebrands as Facet Life Sciences](https://facetlifesciences.com/2017/01/10/virtual-regulatory-solutions-rebrands-as-facet-life-sciences/) - Innovative Development Solutions Company Rebrands to Reflect Broad Product and Service Offerings Wayne, PA, January 10, 2017 – Virtual Regulatory Solutions, a leading provider of development solutions (software and services) for small and growing life sciences teams, today announced that the company is rebranding under the name, Facet Life Sciences. The rebranding effort is a
- [PharmaCyte Biotech Retains Facet Life Sciences to Guide Pancreatic Cancer Therapy Development Lifecycle with FDA](https://facetlifesciences.com/2017/01/30/pharmacyte-biotech-retains-facet-life-sciences-to-guide-pancreatic-cancer-therapy-development-lifecycle-with-fda/) - LAGUNA HILLS, Calif., Jan. 30, 2017 (GLOBE NEWSWIRE) – PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, officially announced today that PharmaCyte has retained Facet Life Sciences, Inc. (Facet) to guide PharmaCyte through its pancreatic cancer therapy development
- [Developing Therapies In a Lean Organization Using On Demand Expertise](https://facetlifesciences.com/2017/08/21/developing-therapies-in-a-lean-organization-using-on-demand-expertise/) - By Ken VanLuvanee There appear to be two diverging strategies emerging in the life sciences industry these days – mega-consolidation (mergers and acquisitions) aimed at “efficiencies of scale,” and leaner, more focused organizations that make use of the best resources at the right times, regardless of where those resources exist (most life sciences companies are
- [Facet Life Sciences Appoints Tobias Massa, Ph.D. to Board of Directors](https://facetlifesciences.com/2017/09/12/facet-life-sciences-appoints-tobias-massa-ph-d-to-board-of-directors/) - Seasoned Life Sciences Expert Joins Innovative Development Solution Provider Wayne, PA, September 12, 2017 – Facet Life Sciences, a leading provider of development solutions (software and services) for small and growing life sciences teams, today announced that Tobias Massa, PhD has joined the company’s Board of Directors. Dr. Massa brings 38 years of success in
- [Facet Life Sciences Reaches Out to Small Biopharmaceutical Teams](https://facetlifesciences.com/2017/10/18/facet-life-sciences-reaches-out-to-small-biopharmaceutical-teams/) - Facet Seeks to Help Small Teams Prepare for Their First IND Wayne, PA October 18, 2017 – Facet Life Sciences, a leading provider of development solutions (software and services) for small and rapidly growing life sciences teams, today announced their participation in two global events. The Facet team will conduct a webinar on Thursday, 19
- [The Myth of Being Special](https://facetlifesciences.com/2017/11/01/the-myth-of-being-special/) - by Lisa Jenkins VanLuvanee I believe that people are special. They are a unique combination of both intrinsic factors and external experiences. Even identical twins who share the same genetic compliment are different from one another in personality, desires, goals, objectives, and lifestyles. Like a snowflake, no two people on this earth are alike. Thank
- [Facet Life Sciences Announces Strong 2017 Performance](https://facetlifesciences.com/2018/01/24/facet-life-sciences-announces-strong-2017-performance/) - Growth Reflects Increasing Needs of Small Life Sciences Teams Wayne, PA, January 24, 2018 – Facet Life Sciences, a leading provider of development software and services for small and growing life sciences teams, today announced that the company witnessed record growth in 2017. Notable business metrics included a 76% increase in services revenue over 2016.
- [Facet Life Sciences to Attend Bio 2018](https://facetlifesciences.com/2018/06/01/facet-life-sciences-to-attend-bio-2018/) - Company to Promote Solutions Designed for Early Stage Life Sciences Teams Wayne, PA, June 1, 2018 – Facet Life Sciences, a leading provider of development software and services for small and growing life sciences teams, today announced that the company will be exhibiting at the BIO 2018 International Convention in Boston on June 5 -
- [Facet Team Member Contributes to Pediatric Dermatology Publication](https://facetlifesciences.com/2018/09/19/ffacet-team-member-contributes-to-recent-pediatric-dermatology-publication/) - Head of R&D Co-authors Journal Article Wayne, PA, September 19, 2018 – Facet Life Sciences, a leading provider of development software and services for small and growing life sciences teams, today announced the publication of “Clinical studies evaluating abametapir lotion, 0.74%, for the treatment of head louse infestation” in Pediatric Dermatology, the official journal of
- [DMS, Document Sharing & eRoom Technologies: What’s Right For You?](https://facetlifesciences.com/2018/10/31/dms-document-sharing-eroom-technologies-whats-right-for-you/) - By Ken VanLuvanee Recently in our conversations with sponsors, we’ve seen a significant uptick in clients using electronic means beyond just storage on hard drives to manage their documents. That’s a wonderful thing to see and we’re thrilled. In this age of purely electronic assets and required electronic only communication with global health authorities, to
- [The Sky is Not Falling: Product Development Can and Should Progress During The Government Shut Down!](https://facetlifesciences.com/2019/01/15/the-sky-is-not-falling-product-development-can-and-should-progress-during-the-government-shut-down/) - The effects of the U.S. government shut down and the impact on how FDA is working is all anyone seems to be talking about. Chicken Little is clucking that there is no end in sight! For the small company, delays can be disastrous. However, product development can and chicken littleshould continue! Now is a great
- [FDA and Intellectual Property Strategies for Medical Device Technologies](https://facetlifesciences.com/2019/02/21/fda-and-intellectual-property-strategies-for-medical-device-technologies/) - Book on Regulatory Practice and Intellectual Property Now Available Wayne, PA, February 21, 2019 – Facet Life Sciences, a leading provider of development software and services for small and growing life sciences teams, today announced the availability of a new book, “FDA and Intellectual Property Strategies for Medical Device Technologies”, in which two of Facet’s
- [Facet Life Sciences Appoints New Chief Operating Officer](https://facetlifesciences.com/2019/03/12/facet-life-sciences-appoints-new-chief-operating-officer/) - R&D Executive Promoted to Ensure Continued Services and Technology Growth Wayne, PA, March 12, 2019 – Facet Life Sciences, a leading provider of development software and services for small and growing life sciences teams, today announced the appointment of Dr. Lisa Jenkins VanLuvanee as Chief Operating Officer. Effective March 1, 2019, Dr. Lisa Jenkins VanLuvanee
- [FDA Meetings: When More Meetings are a Good Thing!](https://facetlifesciences.com/2019/02/26/fda-meetings-when-more-meetings-are-a-good-thing/) - Most of us are trying to simplify our schedules and remove meetings from our calendars. However, there is one scenario where the potential for more meetings is actually a good thing. That is when you are preparing to submit a regulatory application to a health authority, such as an Investigational New Drug Application (IND) to
- [Facet Life Sciences Redefines NDA Timelines - Shattering Industry Standards](https://facetlifesciences.com/2020/12/16/facet-life-sciences-redefines-nda-timelines-shattering-industry-standards/) - FDA files NDAs submitted less than six seeks after completion of clinical program – shattering industry standards WAYNE, PA., DECEMBER 16, 2020 – Facet Life Sciences, a leading provider of development software and services for small and growing life sciences teams, today announced the achievement of a landmark milestone that redefines accepted industry timelines. Facet
- [Are You a Drug or Device?](https://facetlifesciences.com/2022/01/18/are-you-a-drug-or-device/) - Are You a Drug or Device?Unseen Regulatory and Intellectual Property Impact of Genus Regulatory history was made on 9 August 2021 in a Federal Register notice (Docket No: FDA-2021-N-0843) announcing that in accordance with the Genus decision, FDA intends to regulate products that meet both drug and device definition as medical devices, except where the
- [Theragnostics Announces US FDA Approval for its Radiodiagnostic Imaging Drug NephroScanTM](https://facetlifesciences.com/2022/02/23/theragnostics-announces-us-fda-approval-for-its-radiodiagnostic-imaging-drug-nephroscantm/) - Theragnostics Announces US FDA Approval for its Radiodiagnostic Imaging Drug NephroScan™ (Kit for the Preparation of Technetium Tc 99m Succimer Injection) NephroScan is now US FDA approved for the preparation of Tc-99m DMSA NephroScan aids in the detection of kidney cortical defects in adult and pediatric patients, including term neonates GE Healthcare to commence distribution in the
- [Potential Errors and Corrections in Early Phase Drug Development](https://facetlifesciences.com/2022/05/04/potential-errors-and-corrections-in-early-phase-drug-development/) - Learn about common pitfalls and effective strategies in early-phase drug development. Facet Life Sciences helps ensure your project's success from the start.
- [Facet Life Sciences Announces Spinout of Software Division to a New Company: Kivo](https://facetlifesciences.com/2022/01/18/facet-life-sciences-announces-spinout-of-software-division-to-kivo/) - Facet Life Sciences Announces Spinout of Software Division to a New Company: Kivo Facet Life Sciences, a leading provider of regulatory strategy and consulting services, today announced it is spinning out its popular Gemstone Electronic Document Management System to an independent company named Kivo with new leadership and investment. "The decision to spin Gemstone out
- [Facet Life Sciences Recognizes Dana Blue's Achievements](https://facetlifesciences.com/2023/03/09/facet-life-sciences-recognizes-dana-blues-achievements/) - We’re very proud to recognize Dana B.'s recent achievements! Dana has accepted a role as a Group Leader on the AMWA Annual Conference Executive Committee. In this role, she is responsible for spearheading a team of industry experts to guide the annual meeting program content. Dana has also accepted the role of Member Resources Chair for the Indiana Chapter of
- [Facet Life Sciences Celebrates Lisa Vanluvanee](https://facetlifesciences.com/2023/03/27/facet-life-sciences-celebrates-lisa-vanluvanee/) - 10 years!! Congratulations to Dr. Lisa Jenkins VanLuvanee. Thank you for your dedication to cutting edge science and for 10 years of extraordinary leadership and guidance.
- [Facet Life Sciences Recognizes Bill Hodnick's Achievements](https://facetlifesciences.com/2023/03/30/facet-life-sciences-recognizes-bill-hodnicks-achievements/) - Facet is on the cutting edge again! Congratulations to Dr. Bill Hodnick on his upcoming publication. "Potential Use of the Mitomycin Analogue BMY25282 as a Superior Hypoxia Targeted Anticancer Agent"
- [Spotlight On - Q1 2023](https://facetlifesciences.com/2023/04/17/spotlight-on-q1-2023/) - Discover featured projects and success stories from Q1 2023. See how Facet Life Sciences partners with clients to achieve regulatory success.
- [Did You Know - Q1 2023](https://facetlifesciences.com/2023/04/17/did-you-know-q1-2023/) - Explore key insights and updates from Q1 2023 in the life sciences industry. Stay informed with Facet Life Sciences' latest news and developments.
- [FDA Round Up - Q1 2023](https://facetlifesciences.com/2023/04/17/fda-round-up-q1-2023/) - Catch up on FDA updates and industry insights from Q1 2023. Facet Life Sciences provides essential information for navigating regulatory landscapes.
- [Facet By The Numbers - Q1 2023](https://facetlifesciences.com/2023/04/17/facet-by-the-numbers-q1-2023/) - Check out our strategic achievements and milestones from Q1 2023. Facet Life Sciences continues to drive innovation and success in regulatory consulting.
- [Facet Life Sciences Introduces Dynamic Careers Pages on Website](https://facetlifesciences.com/2023/07/18/facet-life-sciences-introduces-dynamic-careers-pages-on-website/) - Explore career opportunities at Facet Life Sciences with our new dynamic careers pages. Join us and contribute to life-changing innovations.
- [Facet Life Sciences Quarterly Update Q2 - 2023](https://facetlifesciences.com/2023/07/26/facet-life-sciences-quarterly-update-q2-2023/) - Discover Facet Life Sciences' Q2 2023 quarterly report, showcasing significant milestones, market trends, and innovations in biotechnology.
- [Spotlight On - Q2 2023](https://facetlifesciences.com/2023/07/27/spotlight-on-q2-2023/) - Explore highlighted projects and achievements from Q2 2023. Facet Life Sciences partners with clients to achieve impactful regulatory milestones.
- [Facet Life Sciences Team Focus – Q2 2023](https://facetlifesciences.com/2023/07/27/facet-life-sciences-team-focus-q2-2023/) - Meet the dedicated team behind Facet Life Sciences' achievements in Q2 2023. Discover how our experts drive regulatory and scientific success.
- [Did You Know - Q2 2023](https://facetlifesciences.com/2023/07/27/did-you-know-q2-2023/) - Stay up to date with noteworthy industry highlights, insights, and progress from Q2 of 2023, brought to you by Facet Life Sciences.
- [FDA Round Up - Q2 2023](https://facetlifesciences.com/2023/07/27/fda-round-up-q2-2023/) - Stay informed with key FDA updates and developments from Q2 2023. Facet Life Sciences provides essential regulatory insights for industry success.
- [Facet By The Numbers - Q2 2023](https://facetlifesciences.com/2023/07/27/facet-by-the-numbers-q2-2023/) - FACET BY THE NUMBERS Total submissions to FDA April – June 2023: 35 (on average almost 3 submissions a week!) Early-stage development highlights: preparation/submission of 3 new INDs and submitted over 22 IND amendments (e.g., new protocols/amendments, CMC updates, nonclinical study reports, annual reports, safety reporting/DSURs); conducted formal meetings with CDER; prepared several gap analyses and
- [Spotlight On - Q3 2023](https://facetlifesciences.com/2023/10/27/spotlight-on-q3-2023/) - Discover standout projects and success stories from Q3 2023. Facet Life Sciences continues to drive innovation in regulatory consulting.
- [Spotlight On Rare Disease Development - Q3 2023](https://facetlifesciences.com/2023/10/27/spotlight-on-rare-disease-development-q3-2023/) - Explore Facet Life Sciences' focus on rare disease development in Q3 2023, highlighting groundbreaking projects and innovative strategies.
- [Did You Know - Q3 2023](https://facetlifesciences.com/2023/10/27/did-you-know-q3-2023/) - Uncover key facts and insights from Q3 2023. Facet Life Sciences shares the latest trends and developments in the life sciences industry.
- [Facet By The Numbers - Q3 2023](https://facetlifesciences.com/2023/10/27/facet-by-the-numbers-q3-2023/) - Review our progress and milestones achieved in Q3 2023. Facet Life Sciences strengthens its commitment to regulatory excellence.
- [Getting To and Through FDA with Bill Hodnick](https://facetlifesciences.com/2023/11/20/getting-to-and-through-fda-with-bill-hodnick/) - Join Bill Hodnick from Facet Life Sciences as he shares insights on navigating the FDA process effectively, from concept to approval.
- [Facet Life Sciences Holiday Gift Guide: Because Even Santa Needs Regulatory Expertise!](https://facetlifesciences.com/2023/12/07/facet-life-sciences-holiday-gift-guide-because-even-santa-needs-regulatory-expertise/) - Explore Facet Life Sciences' unique holiday gift guide, showcasing how regulatory expertise is essential even during festive seasons.
- [Getting To and Through FDA with Jason Mercer](https://facetlifesciences.com/2024/01/29/getting-to-and-through-fda-with-jason-mercer/) - Learn from Jason Mercer as he discusses strategies for successfully navigating FDA processes, presented by Facet Life Sciences.
- [Facet Life Sciences Quarterly Update Q4 - 2023](https://facetlifesciences.com/2024/02/13/facet-life-sciences-quarterly-update-q4-2023/) - Access Facet Life Sciences' Q4 2023 quarterly review, outlining key accomplishments, future projections, and initiatives shaping the biotech sector.
- [Spotlight On Rare Disease Development - Q4 2023](https://facetlifesciences.com/2024/02/13/spotlight-on-rare-disease-development-q4-2023/) - Explore Facet Life Sciences' dedicated efforts in rare disease development during Q4 2023, highlighting new strategies and successes.
- [Did You Know - Q4 2023](https://facetlifesciences.com/2024/02/13/did-you-know-q4-2023/) - Uncover key industry insights and trends from Q4 2023 with Facet Life Sciences' informative 'Did You Know' series.
- [FDA Round Up - Q4 2023](https://facetlifesciences.com/2024/02/13/fda-round-up-q4-2023/) - Stay up to date with all essential FDA developments and analysis from Q4 2023, brought to you by Facet Life Sciences.
- [The Growing Importance of Real-World Evidence in Product Development](https://facetlifesciences.com/2024/10/10/real-world-evidence/) - Unlock the potential of real-world evidence to accelerate product development, improve FDA approval times, and enhance market success with Facet Life Sciences.
- [Strong Regulatory Leadership Guidance in Streamlining Product Development](https://facetlifesciences.com/2024/10/16/strong-regulatory-leadership-guidance-in-streamlining-product-development/) - Streamline regulatory submissions and accelerate product development with strategic leadership that aligns business goals and meets FDA requirements.
- [New Draft FDA Guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices (September 20, 2024)](https://facetlifesciences.com/2024/10/21/new-draft-fda-guidance-chemical-analysis-for-biocompatibility-assessment-of-medical-devices-september-20-2024/) - FDA issued a draft guidance for industry and FDA staff on Chemical Analysis for Biocompatibility Assessment of Medical Devices. Any medical device in which all or part of the device is in contact with the human body requires an assessment of the biocompatibility of that device or device component as part of the premarket submission.

## Pages

- [Home](https://facetlifesciences.com/) - Facet Life Sciences guides emerging biotech from R&D to FDA approval with expert regulatory strategy, product development, and submission support.
- [Drug Development Consulting Services](https://facetlifesciences.com/drug-development-consulting-services/) - Facet Life Sciences' flagship drug development consulting services offers premier solutions for complex regulatory challenges in the life sciences sector.
- [Critical Regulatory & Development Support for Rare Disease Innovations](https://facetlifesciences.com/critical-regulatory-development-support-for-rare-disease-innovations/) - Critical Regulatory & Development Support for Rare Disease Innovations Many promising rare disease candidates stall early because development teams lack regulatory and commercial expertise. Where precedent is limited, Facet helps you understand and leverage every feasible pathway. Where precedent doesn’t exist, we will work with you to create one. Join Us in the Fight Against
- [Rare Disease Causes We Champion](https://facetlifesciences.com/about-rare-disease/) - Rare Disease Causes We Champion Facet Life Sciences was built on the belief that the rarity or complexity of a disease should never determine the urgency of its treatment. We bring precision, speed, and compassion to drug development for conditions that have been overlooked for too long — and we show up for the families
- [Publications](https://facetlifesciences.com/resources-1/publications/) - Browse the latest publications by Facet Life Sciences, providing insights and updates on regulatory practices and life sciences innovations.
- [Resource Center](https://facetlifesciences.com/resources/) - Discover Facet Life Sciences' comprehensive resource hub, featuring case studies, publications, webinars, and more for industry insights.
- [Case Studies](https://facetlifesciences.com/resources-1/case-studies/) - Product Development Case Studies | Facet Life Sciences
- [Careers](https://facetlifesciences.com/careers/) - Join Facet Life Sciences and make an impact in regulatory consulting. Explore career opportunities with a dynamic and innovative team.
- [RECRUITMENT PROCESS](https://facetlifesciences.com/careers/recruitment-process/) - Understand the recruitment process at Facet Life Sciences, designed to attract and retain top talent committed to regulatory success.
- [FDA Regulatory Consulting](https://facetlifesciences.com/fda-regulatory-consulting/) - Facet provides FDA regulatory consulting services designed for small to mid-sized biotechs. Talk to a regulatory expert today.
- [OUR CULTURE](https://facetlifesciences.com/careers/our-culture/) - Learn about the vibrant culture at Facet Life Sciences, fostering innovation, teamwork, and career development in regulatory consulting.
- [CAREER OPPORTUNITIES](https://facetlifesciences.com/careers/career-opportunities/) - Explore exciting career opportunities at Facet Life Sciences, where your talent and expertise can thrive in a collaborative environment.
- [BENEFITS](https://facetlifesciences.com/careers/benefits/) - Discover the comprehensive benefits offered by Facet Life Sciences, supporting our employees' professional growth and personal well-being.
- [Board of Directors](https://facetlifesciences.com/about/board-of-directors/) - Meet the Board of Directors at Facet Life Sciences, composed of industry leaders guiding strategic direction and regulatory excellence.
- [Our Partners](https://facetlifesciences.com/our-partners/) - Explore Facet Life Sciences' collaborations with partners across the industry, fostering success through strategic alliances and shared expertise.
- [About Facet Life Sciences](https://facetlifesciences.com/about/) - Learn about Facet Life Sciences, where scientific and regulatory expertise empowers life sciences companies from concept to commercialization.
- [Contact Us](https://facetlifesciences.com/contact/) - Get in touch with Facet Life Sciences for inquiries about our services and discover how we can support your regulatory needs.
- [Gap Analysis Services](https://facetlifesciences.com/gap-analysis-services/) - Providing expert gap analysis services to help small life sciences companies identify development gaps, and align R&D with regulatory requirements.
- [Psychedelics](https://facetlifesciences.com/psychedelics/) - Navigate the evolving field of psychedelics with Facet Life Sciences, offering expert regulatory support and strategic development advice.
- [Regulatory](https://facetlifesciences.com/regulatory/) - Accelerate FDA approval with Facet Life Sciences’ expert Regulatory Consulting team. Get guidance on complex regulatory affairs & achieve success the 1st time.
- [Radiopharmaceuticals](https://facetlifesciences.com/drug-development-consulting-services/pet-radiopharm/) - Discover specialized diagnostic & theranostic radiopharmaceutical services at Facet Life Sciences, providing expert support in regulatory compliance.
- [FDA Meeting Consulting](https://facetlifesciences.com/fda-meeting-consulting/) - FDA regulatory consultants who help life sciences companies secure clear, actionable outcomes in meetings with FDA that speed development and approvals.
- [Clinical Regulatory Affairs Director](https://facetlifesciences.com/clinical-regulatory-affairs-director/) - Clinical Regulatory Affairs Director (Remote) At Facet, our mission is to make life sciences dreams a reality. We are regulatory and development leaders with a passion for designing and leading the implementation of innovative strategies and tactical solutions to advance great science. Our experience enables us to deliver streamlined and innovative solutions for small organizations
- [Senior Regulatory Writer – Clinical](https://facetlifesciences.com/senior-regulatory-writer-clinical/) - Job Description: Senior Regulatory Writer – Clinical (Remote) At Facet, our mission is to make life sciences dreams a reality. We are regulatory and development leaders with a passion for designing and implementing innovative strategies and tactical solutions to advance great science. Our experience enables us to deliver streamlined and innovative solutions for small organizations
- [Product Development Champion](https://facetlifesciences.com/product-development-champion/) - Rely on Facet Life Sciences as your product development champion, guiding your innovations from concept through commercialization.
- [Asset Value](https://facetlifesciences.com/asset-value/) - Grow the full potential of your asset value at every stage of development with Facet Life Sciences’ comprehensive asset valuation services.
- [General Therapeutic Areas](https://facetlifesciences.com/general-therapeutic-areas/) - Explore Facet Life Sciences' expertise across a range of general therapeutic areas, providing strategic support for diverse medical innovations.
- [Oncology](https://facetlifesciences.com/oncology-drug-development/) - Specialized oncology drug development services from Facet Life Sciences'. Supporting regulatory strategies and clinical development for cancer therapies.
- [Strategic Statistical Services](https://facetlifesciences.com/strategic-statistical-services/) - Engage Facet Life Sciences' strategic statistical services for robust data analysis and support in your regulatory submissions and studies.
- [Regulatory Submission Leadership](https://facetlifesciences.com/regulatory-submission-leadership/) - Trust Facet Life Sciences for regulatory submission leadership, ensuring your documentation meets all necessary compliance standards for approval.
- [Meeting with the FDA](https://facetlifesciences.com/meeting-with-the-fda/) - Prepare for FDA meetings with Facet Life Sciences' expert guidance, ensuring effective communication and successful regulatory outcomes.
- [Medical Writing of Submission Documents](https://facetlifesciences.com/medical-writing-of-submission-documents/) - Learn about Facet Life Sciences' professional medical writing services, crafting precise and compliant submission documents for regulatory approval.
- [Strategic & Regulatory Development Guidance](https://facetlifesciences.com/strategic-regulatory-development-guidance/) - Utilize Facet Life Sciences' strategic regulatory development guidance to navigate complex processes with tailored solutions for success.
- [Gap Analysis](https://facetlifesciences.com/gap-analysis/) - Utilize our gap analysis services at Facet Life Sciences to identify and address compliance gaps in your regulatory strategies.
- [US Agent](https://facetlifesciences.com/us-agent/) - Rely on Facet Life Sciences as your US Agent for representing your interests and ensuring compliance with FDA regulations and standards.
- [Privacy Policy](https://facetlifesciences.com/privacy-policy/) - Review the privacy policy of Facet Life Sciences to understand our commitment to protecting your personal and professional information.
- [Senior Regulatory Writer - CMC](https://facetlifesciences.com/senior-regulatory-writer-cmc/) - Learn about the role of a Senior Regulatory Writer at Facet Life Sciences, contributing expertise in CMC regulatory writing and ensuring compliance.
- [Strategic Statistical Consultant](https://facetlifesciences.com/strategic-statistical-consultant/) - Learn about the role of a Strategic Statistical Consultant at Facet Life Sciences, contributing expertise in statistical programming and clinical trial design.
- [ophthalmology](https://facetlifesciences.com/ophthalmic-drug-development/) - Our expertise in ophthalmic drug development services provides insight and regulatory support for eye care and vision-related therapies.
- [Learning Links](https://facetlifesciences.com/resources-1/learning-links/) - Access curated learning links by Facet Life Sciences, offering valuable resources for staying informed on regulatory and scientific advancements.
- [Webinar Library](https://facetlifesciences.com/resources-1/webinar-library/) - Visit Facet Life Sciences' webinar library for on-demand access to expert-led discussions on key topics in life sciences and regulatory affairs.
- [Senior Medical Writer](https://facetlifesciences.com/senior-medical-writer/) - Learn about the role of a Senior Medical Writer at Facet Life Sciences, contributing expertise in crafting regulatory submission documents.
- [Contact Us Thank You](https://facetlifesciences.com/contact-us-thank-you/)
- [Download Form: How Facet Gemstone Addresses 21CFR Part 11 Compliance for Electronic Document Management](https://facetlifesciences.com/download-form-how-facet-gemstone-addresses-21cfr-part-11-compliance-for-electronic-document-management/) - Please complete the following form to download the whitepaper
- [Schedule An Introduction](https://facetlifesciences.com/schedule/) - Facet is a team of clinical, nonclinical, CMC, FDA regulatory, biostats, and commercialization experts focused exclusively on the success of small organizations. Accelerate your path forward by booking an introduction with Bob and a member of the Facet team. This browser does not support Iframe Awards & Recognition
- [Podcasts](https://facetlifesciences.com/resources-1/podcasts/) - PodcastsIND-Stage Regulatory and Patent AnalysisPresented by Lisa VanLuvanee and Jeremy A. Cubert
- [When is a Drug Not a Drug](https://facetlifesciences.com/when-is-a-drug-not-a-drug/) - So, when is a drug not a drug? To tackle this question, let’s first consider the US regulatory definitions of drugs and devices: Per FD&C Act Section 201(g)(1), a drug is defined as: …intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. …articles (other than food)
- [Gemstone Island Quiz](https://facetlifesciences.com/gemstone-island-quiz/) - Gemstone is now Kivo! Documents: Managed. Kivo provides 360-degree visibility from document authoring through submission Visit Kivo.io
- [Facet Gemstone](https://facetlifesciences.com/gemstone/) - Gemstone is now Kivo! Documents: Managed. Kivo provides 360-degree visibility from document authoring through submission Visit Kivo.io
- [Request a Demo of Facet Gemstone](https://facetlifesciences.com/gemstone/request-a-demo/) - Gemstone is now Kivo! Documents: Managed. Kivo provides 360-degree visibility from document authoring through submission Visit Kivo.io
- [Gemstone Capabilities](https://facetlifesciences.com/gemstone-capabilities/) - Gemstone is now Kivo! Documents: Managed. Kivo provides 360-degree visibility from document authoring through submission Visit Kivo.io
- [Drug or Device Replay](https://facetlifesciences.com/drug-or-device-replay/) - Live Webinar: Are You a Drug or Device? Date: 11/23/2021 Time: 2pm eastern Play recording (1 hr 33 mins) Recording password: YcrfrUf4
- [Drug or Device Roundtable](https://facetlifesciences.com/drug-or-device-roundtable/) - Live Webinar: Are You a Drug or Device? Date: 11/23/2021 Time: 2pm eastern Register to Watch the Replay[fusion_modal name=”dodwebinar” title=”Watch The Replay” size=”large” background=”” border_color=”” show_footer=”yes” class=”” id=””] Please enable JavaScript in your browser to complete this form.Name *FirstLastEmail *Phone NumberCompany *TitleHow can we help you today?WebsiteSubmit [/fusion_modal]Unseen Regulatory and Intellectual Property Impact of Genus
- [Download Form: Document Management for Small Biotech Companies: An Executive Perspective](https://facetlifesciences.com/resources-1/whitepapers/download-form-document-management-for-small-biotech-companies-an-executive-perspective/) - Please complete the following form to download the whitepaper
- [Associate Product Development Champion](https://facetlifesciences.com/associate-product-development-champion/) - The Regulatory Affairs Coordinator (called an Associate Product Development Champion [APDC] at Facet) is a Product Development Champion in training. The APDC provides guidance and support to Facet clients at all stages of regulated development with support from the Vice President, Research and Development, and other Facet product Development Champions. The APDC will support the implementation of innovative regulatory strategies based on client input (stated goals, corporate objectives,
- [Download Form: Small Team Rapidly Deploys Gemstone for Compliant Document Management Capabilities](https://facetlifesciences.com/resources-1/case-studies/download-form-small-team-rapidly-deploys-gemstone-for-compliant-document-management-capabilities/) - Please complete the following form to download the case study
- [Download Form: Facet Gemstone Helps Virtual Teams Manage Submission Document Authoring Process](https://facetlifesciences.com/resources-1/case-studies/download-form-facet-gemstone-helps-virtual-teams-manage-submission-document-authoring-process/) - Please complete the following form to download the case study
- [Download Form: Facet Life Sciences Identifies Need and Fills Resourcing  Gaps with Biometrics Expertise](https://facetlifesciences.com/resources-1/case-studies/download-form-facet-life-sciences-identifies-need-and-fills-resourcing-gaps-with-biometrics-expertise/) - Please complete the following form to download the case study
- [Download Form: Facet Life Science Saves Time and Money for European Diagnostics Sponsor](https://facetlifesciences.com/resources-1/case-studies/download-form-facet-life-science-saves-time-and-money-for-european-diagnostics-sponsor/) - Please complete the following form to download the case study
- [Download Form: Facet Life Sciences Provides Laser Focus on Clinical Development](https://facetlifesciences.com/resources-1/case-studies/download-form-facet-life-sciences-provides-laser-focus-on-clinical-development/) - Please complete the following form to download the case study
- [Download Form: The Right Tool Makes the Job Easier](https://facetlifesciences.com/resources-1/whitepapers/download-form-the-right-tool-makes-the-job-easier-actions/) - Please complete the following form to download the whitepaper
- [Upcoming Events](https://facetlifesciences.com/news/events/) - SNMMI 2020 Annual Conference in New Orleans June 13-16, 2020 New Orleans Ernest N. Morial Convention Center New Orleans, Louis Booth #1063 SNMMI 2020 Official Event Website
- [Sample Page](https://facetlifesciences.com/sample-page/) - This is an example page. It's different from a blog post because it will stay in one place and will show up in your site navigation (in most themes). Most people start with an About page that introduces them to potential site visitors. It might say something like this: Hi there! I'm a bike messenger
- [Thank You](https://facetlifesciences.com/thank-you/) - [vc_row][vc_column][ultimate_heading main_heading=”Thank You!” heading_tag=”h1″ spacer=”line_only” spacer_position=”bottom” line_height=”3″ line_color=”#172d53″ spacer_margin=”margin-bottom:50px;”][/ultimate_heading][/vc_column][/vc_row][vc_row][vc_column][vc_column_text] Your information has successfully been submitted. We’ll be in touch. Where to next? [/vc_column_text][/vc_column][/vc_row][vc_row bg_type=”image” parallax_style=”vcpb-default” bg_image_new=”id^5473|url^https://facetlifesciences.com/wp-content/uploads/2016/12/background.jpg|caption^null|alt^null|title^background|description^null” css=”.vc_custom_1568308361961{border-radius: 2px !important;}”][vc_column width=”1/3″ css=”.vc_custom_1568308304447{border-radius: 2px !important;}”][ult_buttons btn_title=”Services” btn_link=”url:https%3A%2F%2Fwww.facetlifesciences.com%2Fflagship-services%2F|||” btn_align=”ubtn-center” btn_bg_color=”#496fb6″ icon_size=”32″ btn_icon_pos=”ubtn-sep-icon-at-left”][/vc_column][vc_column width=”1/3″][ult_buttons btn_title=”Gemstone” btn_link=”url:https%3A%2F%2Fwww.facetlifesciences.com%2Fgemstone%2F|||” btn_align=”ubtn-center” btn_bg_color=”#c8415c” icon_size=”32″ btn_icon_pos=”ubtn-sep-icon-at-left”][/vc_column][vc_column width=”1/3″][ult_buttons btn_title=”Home” btn_link=”url:https%3A%2F%2Fwww.facetlifesciences.com%2F|||” btn_align=”ubtn-center” btn_bg_color=”#496fb6″ icon_size=”32″ btn_icon_pos=”ubtn-sep-icon-at-left”][/vc_column][/vc_row]
- [FDA Meeting Prep](https://facetlifesciences.com/fda-meeting-prep/) - [vc_row][vc_column][ultimate_heading main_heading=”Preparing for FDA Meetings” heading_tag=”h1″ spacer=”line_only” spacer_position=”bottom” line_height=”3″ line_color=”#172d53″ spacer_margin=”margin-bottom:50px;”][/ultimate_heading][vc_single_image image=”6510″ img_size=”full” alignment=”center”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]At Facet, we take a fresh approach to preparing for and participating in FDA meetings that has a proven track record of success. We meet with FDA on average once every week. We are experienced and our approaches work. We have used
- [Resource Center - alt](https://facetlifesciences.com/resources-1/) - Select one of the following categories to access our resource files. New! Listen at your Leisure to Facet Life Sciences’ Podcasts! [siteorigin_widget class=”SiteOrigin_Widget_Image_Widget”][/siteorigin_widget] [siteorigin_widget class=”SiteOrigin_Widget_Button_Widget”][/siteorigin_widget] [siteorigin_widget class=”SiteOrigin_Widget_Image_Widget”][/siteorigin_widget] [siteorigin_widget class=”SiteOrigin_Widget_Button_Widget”][/siteorigin_widget] [siteorigin_widget class=”SiteOrigin_Widget_Image_Widget”][/siteorigin_widget] [siteorigin_widget class=”SiteOrigin_Widget_Button_Widget”][/siteorigin_widget]
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- [Home](https://facetlifesciences.com/home-2/) - Create a boost with your unique ideas using Avada. Proin eu varius felis. Pellentesque hendrerit elit ornare, ultricies ante eu, vestibulum dui. Quisque venenatis sollicitudin felis eget dictum. Aliquam tincidunt felis orci, ut malesuada ligula malesuada in. Integer lacinia nulla eget nunc lacinia, ac rhoncus velit molestie. Donec sit amet fringilla enim. Nulla facilisi. In
- [News](https://facetlifesciences.com/news/) - [vc_row][/vc_row][vc_column][/vc_column][vc_column_text]I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo. [/vc_column_text][vc_row][vc_column][vc_wp_posts title=”The Latest News” number=”5″][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Facet Life Sciences is in the news! Check out our announcements below![/vc_column_text][/vc_column][/vc_row]

## Portfolio

- [Taylor McNeely, MS](https://facetlifesciences.com/portfolio/taylor-mcneely-ms/) - Strategic Regulatory Writer As the son of a teacher and a liquor store manager, Taylor was drawn to medical writing because it balances the dual drives for perfection and collaborative fun. As a person who values competence and consistency, Taylor balances his high standards and attention to detail with a dry sense of humor and
- [Lisa Jenkins VanLuvanee, Ph.D.](https://facetlifesciences.com/portfolio/lisa-jenkins-vanluvanee-ph-d/) - Chief Values Officer I grew up in State College, Pennsylvania, and come from a family of dentists (and serious flossers). From an early age I knew that, although flossing was important, my passion lay elsewhere. I went to Juniata College for my undergraduate degree and did my graduate work at Syracuse University. When I wasn’t
- [Randy Goodman, Ph.D., MHA, FACHE, PMP, BCMAS](https://facetlifesciences.com/portfolio/randy-goodman-ph-d/) - Discover Randy Goodman's Ph.D. portfolio at Facet Life Sciences, highlighting his professional achievements and significant contributions to the industry.
- [Michelle Byrne, BME, RAC](https://facetlifesciences.com/portfolio/michelle-byrne/) - Product Development Champion Although she’s now considered an East Coaster, Michelle was born and raised in the Midwest. She also spent time living in the South and on the West Coast. In fact, her California friends thought she was crazy for leaving. No one moves to California and leaves, they all teased. Alas, despite the
- [Josh Eldridge, Ph.D.](https://facetlifesciences.com/portfolio/josh-eldridge-phd/) - Product Development Champion Josh grew up on a 20 acre farm in Kentucky. At some moment, he decided that chemistry was super cool, and that development of medications was a great use of chemical principles. Accordingly, Josh pursued doctoroal studies at the University of Kentucky in Pharmaceutical Sciences where his work focused on transdermal drug
- [Dana Blue, M.S.](https://facetlifesciences.com/portfolio/dana-blue-m-s/) - Strategic Program Champion and Medical Writing Team Manager Dana Blue, M.S., is a Strategic Program Champion at Facet Life Sciences, a company designed to assist small to mid-sized pharmaceutical companies develop, register and maintain drug, biologic, device and generic applications. Dana has approximately 20 years of pharmaceutical experience in a variety of positions ranging across
- [William (Bill) Hodnick, Ph.D., DABT](https://facetlifesciences.com/portfolio/william-bill-hodnick/) - BACKWilliam F. Hodnick, Ph.D., DABT Product Development Champion William (Bill) Hodnick, Ph.D., DABT, is a regulatory and product development expert with extensive experience guiding drug, biologic, device, and combination product programs from IND through post-market requirements. He provides strategic regulatory insight, submission leadership, and scientific expertise for a diverse range of therapeutic innovations. Bill is
- [Frank A. Closurdo](https://facetlifesciences.com/portfolio/frank-a-closurdo/) - Frank A. Closurdo, VP, Commercial Services at Facet Life Sciences, focuses on integrating market value strategies earlier in the product development process.
- [Ken VanLuvanee](https://facetlifesciences.com/portfolio/ken-vanluvanee/) - Ken is an experienced regulatory professional, skillful entrepreneur, and seasoned leader. He has a proven track record of developing innovative solutions to help small companies, with limited resources, operate more efficiently. Throughout his career, Ken has proven himself as an exceptional leader with the ability to build teams of talented regulatory professionals who are able to move beyond normal and achieve true success.
- [Lane Jaeckle Santos, Ph.D., RAC](https://facetlifesciences.com/portfolio/lane-jaeckle-santos-phd-rac/) - Strategic Program Champion and Regulatory Services Team Manager I’ve always been naturally curious and fascinating by how things work. My father is an engineer and was always taking apart things to fix them; I was very used to seeing nuts, bolts, wires, gears, and batteries. But the frozen chickens we made for dinner or crab
- [Tom Hallam, Ph.D., MBA](https://facetlifesciences.com/portfolio/tom-hallam-phd/) - President and Chief Operating Officer I grew up in the Midwest, where summers were spent swimming in lakes and exploring forests, while winters were all about sledding and building snow forts. My small-town upbringing taught me to appreciate life’s simple joys: family, good friends, and the great outdoors. My love for science began early. I
- [Ken VanLuvanee, CEO and Board Chairman](https://facetlifesciences.com/portfolio/ken-vanluvanee-2/) - Ken VanLuvanee is a serial entrepreneur with over 25 years of pharmaceutical and technology expertise. Throughout his career, Mr. VanLuvanee has enjoyed great success in the regulatory process and technology sector of the life sciences industry. Mr. VanLuvanee is currently the President/CEO of Facet Life Sciences. Prior to creating this organization, Mr. VanLuvanee was the
- [Lisa Jenkins VanLuvanee, Ph.D., Chief Values Officer](https://facetlifesciences.com/portfolio/lisa-jenkins-vanluvanee-ph-d-2/) - Lisa Jenkins VanLuvanee, Ph.D., is the Vice President of Research and Development at Facet Life Sciences (formerly Virtual Regulatory Solutions, Inc.). Dr. VanLuvanee has nearly 20 years of experience in the life sciences industry, and her background includes product development planning, global regulatory submission strategy, dossier preparation and submission, and post-approval life-cycle management. She specializes
- [Derick Winkle, MS](https://facetlifesciences.com/portfolio/derick-winkle-ms/) - Product Development Champion Derick’s journey to Facet Life Sciences is built on more than 30 years of chemical, pharmaceutical, and regulatory expertise. While his initial pursuit of an education in chemistry was driven by the opportunities in the field, he quickly found a deep, lifelong passion for the science of organic chemistry. Derick spent the
- [Jason Mercer, Ph.D., RAC](https://facetlifesciences.com/portfolio/jason-mercer/) - Strategic Program Champion Jason grew up in a tiny Texas town about 50 miles north of Dallas. He spent his youth working on his grandparents’ farm helping to care for his grandad’s cattle, bailing hay, and generally enjoying the outdoors. Jason was also actively involved in the Boy Scouts of America, earning the Eagle Scout
- [Jamie Chambers, RAC](https://facetlifesciences.com/portfolio/jamie-chambers/) - Product Development Champion Jamie’s 39-year professional path in the pharma industry started with The Upjohn Company and has taken him from the research laboratory to clinical development and eventually to regulatory affairs. He enjoys being close to the action and being involved in carrying the ball across the goal line (FDA Approval!). Following his stint
- [Justin Leng, PharmD](https://facetlifesciences.com/portfolio/justin-leng-pharmd/) - Associate Product Development Champion Justin’s love of the sciences came from his fourth grade teacher, Mr. Ryan He clearly remembers Mr. Ryan growing bacteria on a petri dishes and absolutely loved seeing what grew! From there, Justin’s fascination of the sciences began – from space to bacteriophages which ultimately lead him into Pharmacy. During Justin’s
- [Marcoita Gilbert, Ph.D., DABT](https://facetlifesciences.com/portfolio/marcoita-gilbert-phd/) - Product Development Champion Marcoita is a Product Development Champion with over 10 years’ professional Toxicology and regulatory consulting experience. Her prior experience includes senior positions in both smaller and larger regulatory consulting firms, and has supported various nonclinical strategies for a variety of products in all stages of development. Her curiosity and interest in the
- [Venita DePuy, Ph.D.](https://facetlifesciences.com/portfolio/venita-depuy-phd/) - View Venita Depuy's Ph.D. portfolio at Facet Life Sciences, presenting her groundbreaking research and specialized expertise in the life sciences sector.
- [Meredith Scarberry, MS](https://facetlifesciences.com/portfolio/meredith-scarberry-ms/) - Explore Meredith Scarberry's comprehensive portfolio at Facet Life Sciences, showcasing her expertise and notable accomplishments in the life sciences field.
- [Amanda Austin, MD](https://facetlifesciences.com/portfolio/amanda-austin-md/) - Strategic Statistical Consultant
- [Eva Raspor, MSc](https://facetlifesciences.com/portfolio/eva-raspor-msc/) - Strategic Statistical Consultant
- [Robert Vollkommer, MBA](https://facetlifesciences.com/portfolio/robert-vollkommer-mba/) - Strategic Statistical Consultant
- [Scott Burian, Ph.D. RAC](https://facetlifesciences.com/portfolio/scott-burian-ph-d-rac/) - Strategic Program Champion Originally hailing from Long Island, New York, Scott, made the journey southward to obtain his degree in biology from Virginia Tech. After completing a clinical trial-based dissertation for his doctorate at Wake Forest University, Scott combined these two experiences to enter the world of pharmaceutical development with a focus on CMC. He
- [Kristen Harrington](https://facetlifesciences.com/portfolio/kristen-harrington/) - Strategic Statistical Consultant Originating from North Carolina, Kristen has spent the majority of her life in various locations between the Appalachian mountains and Atlantic ocean within that state. As an only child for the first twelve years of her life, Kristen’s family was thrilled she ventured only two hours away to North Carolina State University
- [Sarah Woodruff](https://facetlifesciences.com/portfolio/sarah-woodruff/) - Strategic Statistical Consultant Born in Washington, DC, Sarah was raised by an infectious disease pathologist and a clinical psychology professor so her early interest in microbiology and scientific research was unsurprising. Add to that additional degrees in math and statistics as well as bioinformatics and her love of what data can do for you is
- [Nikole Santos](https://facetlifesciences.com/portfolio/nikole-santos/) - Proposals and Contracts Manager Born and raised in Southern California, I am a graduate of California State University, Fullerton and currently reside in San Diego. I began my professional career in operations management, where I led multiple teams and supported meaningful projects for clients across diverse industries, including construction, solar, life sciences, and technology. After
- [Dominique Canlas](https://facetlifesciences.com/portfolio/dominique-canlas/) - Commercial Development Manager I am a Southern California native and currently live in Encinitas, CA. I earned my degree from the University of San Diego. My professional experience has been in business development and commercial operations, supporting teams across the life sciences and healthcare space. I enjoy connecting strategy with execution and helping build strong,
- [Michael Tomasovich, MS RAC](https://facetlifesciences.com/portfolio/michael-tomasovich-ms-rac/) - Product Development Champion Michael Tomasovich is a regulatory affairs expert with over 20 years’ experience focusing on drugs and medical devices with having worked for companies both large and small including firms such as Abbott, BD, Medtronic and Smile Direct Club.
- [Morgan Waad, MS](https://facetlifesciences.com/portfolio/morgan-waad-ms/) - Strategic Regulatory Writer Morgan Waad is a Strategic Regulatory Writer with more than 10 years in the industry and has led drug submissions, complex clinical study reports, clinical study protocols, and other key regulatory documents. She comes from a family of healthcare professionals and chose a career in regulatory writing to combine her strong language
- [Thomas W. Meyer](https://facetlifesciences.com/portfolio/thomas-w-meyer/) - Vice President, Head of Business Development Born and raised in Covington, Kentucky, Tom graduated from Northern Kentucky University. He began his career in the pharmaceutical industry at Kendle International and has worked at a number of CROs over the years. Tom is passionate about working with Emerging Biotech and Pharma companies and has focused the
- [Catherine (Cathy) Kessler](https://facetlifesciences.com/portfolio/catherine-cathy-kessler/) - Product Development Champion Cathy was born, raised, and still lives in the SE corner of Michigan. Her love of the health sciences started as a child as she used to read the Family Medical Guide books for enjoyment. She majored in Biology at Oakland University and got her start working in the Quality Control (QC)
- [Tobias Massa, Ph.D.](https://facetlifesciences.com/portfolio/tobias-massa-ph-d/) - Tobias Massa is a Senior Executive with 38 years of success in pharmaceuticals, biotech, life sciences, and technology. During his career, Tobias assisted in gaining approvals for 27 commercial products and more than 300 investigational products and has coached and mentored over 300 regulatory professionals. From 2014 to 2016, Dr. Massa served as VP and

## FAQs

- [FDA Meetings](https://facetlifesciences.com/faq-items/fda-meetings/) - Type AType B / Type B (EOP)Type DINTERACT and INTERACT “lite”Formal and informal meetings with OOPDPre-Sub (Q-sub)ANDA product development and pre-submissionInformal meetings
- [Therapeutic Area Experience](https://facetlifesciences.com/faq-items/therapeutic-area-experience/) - AllergyCardiovascular/RenalDermatologyDiagnostic and Therapeutic RadiopharmaceuticalsGIImmunologyInfectious DiseaseNeurologyOncologyOphthalmologyPainPsychedelicsPsychiatryReproductive HealthUltra Rare Diseases
- [Regulatory Assets](https://facetlifesciences.com/faq-items/regulatory-assets/) - Breakthrough Designation Fast Track Designation Orphan Designation Rare Diseases Voucher Special Protocol Assessment Tropical Diseases Voucher Small Business Designation
- [Dosage Form Experience](https://facetlifesciences.com/faq-items/dosage-form-experience/) - CapsulesCreamsGelsLiposomesMedical GasesMicrodose PowdersMonoclonal AntibodiesParenterals (liquid lyophilized)Parenterals (powder fill)OverencapsulationPatchesPowdersSynthetic and Semi-synthetic Drug SubstancesTablets (IR and ER)ToothpasteSuppositoriesSwabsVaccines
- [Application Type Experience](https://facetlifesciences.com/faq-items/application-type-experience/) - 505(b)(1) 505(b)(2) 505(j) – ANDA Medical Device Combination Products IND IDE DMF Orphan Breakthrough Rare Pediatric Disease Rare Tropical Disease Small Business

## Categories

- [Blog](https://facetlifesciences.com/category/blog/) - Dive into Facet Life Sciences’ blog for expert articles and insights on regulatory trends, scientific developments, and industry news.
- [Gemstone](https://facetlifesciences.com/category/gemstone/)
- [News Stories](https://facetlifesciences.com/category/news/) - Read the latest news and announcements from Facet Life Sciences. Stay informed about our innovations and industry engagements.
- [Services](https://facetlifesciences.com/category/services/) - Discover the range of services offered by Facet Life Sciences, designed to support life sciences companies from development to approval.
- [Development](https://facetlifesciences.com/category/gemstone/development/)
- [FDA Submission](https://facetlifesciences.com/category/gemstone/fda-submission/)
- [PET Radiopharm](https://facetlifesciences.com/category/pet-radiopharm/)
- [Regulatory](https://facetlifesciences.com/category/regulatory/) - Access comprehensive insights on regulatory strategies and updates from Facet Life Sciences, guiding your path to compliance and approval.
- [IND](https://facetlifesciences.com/category/ind/)
- [NDA/BLA](https://facetlifesciences.com/category/nda-bla/)
- [Clinical](https://facetlifesciences.com/category/clinical/)
- [FDA Meetings](https://facetlifesciences.com/category/fda-meetings/)
- [Nonclinical](https://facetlifesciences.com/category/nonclinical/)
- [CMC](https://facetlifesciences.com/category/cmc/)
- [Psychedelics](https://facetlifesciences.com/category/psychedelics/)
- [Radiopharmaceuticals](https://facetlifesciences.com/category/radiopharmaceuticals/)
- [Cell and Gene Therapy](https://facetlifesciences.com/category/cell-and-gene-therapy/)
- [BTD/Orphan](https://facetlifesciences.com/category/btd-orphan/)
- [Commercial](https://facetlifesciences.com/category/commercial/)
- [Device](https://facetlifesciences.com/category/device/)
- [Blog Archive](https://facetlifesciences.com/category/blog-archive/)
- [Gap Analysis](https://facetlifesciences.com/category/gap-analysis/)

## Tags

- [genus](https://facetlifesciences.com/tag/genus/)
- [FDA](https://facetlifesciences.com/tag/fda/)
- [greatplacetowork](https://facetlifesciences.com/tag/greatplacetowork/) - Explore why Facet Life Sciences is recognized as a great place to work, emphasizing our commitment to a positive and collaborative workplace.
- [CPT](https://facetlifesciences.com/tag/cpt/)
- [2025 CPT Code](https://facetlifesciences.com/tag/2025-cpt-code/)
- [AMA](https://facetlifesciences.com/tag/ama/)

## Portfolio Categories

- [Leadership](https://facetlifesciences.com/portfolio_category/leadership/)
- [Team Members](https://facetlifesciences.com/portfolio_category/team-members/)
- [Board](https://facetlifesciences.com/portfolio_category/board/)