Gain Regulatory Clarity and Build Market Value for Your Bench Innovation
Facet’s core services move product development forward at every stage. The scientists developing the innovative drug or medical device, the regulators evaluating clinical endpoints, and the investors funding it all need different things from the same program. Facet speaks all three languages.
“Facet worked with us as a true partner, taking a team approach to solving problems. Very little was ‘off the table’ when it came to overcoming hurdles.”
Integrated Solutions for Every Stage of Product Development
A defensible path to FDA approval
Regulatory Strategy
Access strategic insights grounded in how regulators interpret data and how approval decisions are made. We build product pathways based on each program’s operational realities, regulatory readiness, and market posture.
Endpoints that support the label you need
Market Value Strategy
Align clinical trial design with competitive labeling claims, payer requirements, and market positioning from the earliest phases. Our regulatory strategists collaborate with our market value team throughout the program’s lifecycle.
Stakeholder-centered storytelling
Asset Positioning
Translate your science into product value at every milestone in the development journey, with asset language your partners, acquirers, or stakeholders can evaluate and act on. Ensure every decision is made with market realities and risk trade-offs front and center.
Serve as designated FDA liaisons, ensuring traceable, ongoing communication between the agency and the sponsor
Identify program gaps before regulators or stakeholders do, and build a practical, cost-conscious risk mitigation plan
Align early research with reviewer intent, and develop a coherent regulatory roadmap that fits production realities and market openings
Prepare background packages and supporting materials that drive productive FDA interactions
Author and coordinate technically precise, submission-ready documents across all application types
Own the full submission lifecycle — managing creation, QC, and finalization
Design lean, efficient trials with statistical modeling and simulation to increase the probability of success in nonclinical and clinical trials
Improve R&D decision-making with asset valuation insights, then translate that science into market-ready language
Our Regulatory and Development Experience
Facet experts guide product development strategies across a broad range of application types, therapeutic areas, and dosage forms. Learn more about our specialized experience:
505(b)(1) – NDA/BLA
505(b)(2) – NDA/BLA
505(j) – ANDA
Medical Device
-510(k)
-De Novo
-PMA
Combination Products
IND
IDE
DMF
Orphan
Breakthrough
Rare Pediatric Disease/Rare Tropical Disease
Small Business
Allergy
Cardiovascular/Renal
Dermatology
Diagnostic and Therapeutic Radiopharmaceuticals
GI
Immunology
Infectious Disease
Neurology
Oncology
Ophthalmology
Pain
Psychiatry
Reproductive Health
Ultra-rare Diseases
Capsules
Creams
Gels
Liposomes
Medical Gases
Microdose Powders
Monoclonal Antibodies
Parenterals (liquid lyophilized, powder fill)
Overencapsulation
Patches
Powders
Synthetic and Semi-synthetic Drug Substances
Tablets (IR and ER)
Toothpaste
Suppositories
Swabs
Vaccines
What We Don’t Do
We are experts at a lot of things, and we want to be equally clear about what we don’t do. We get asked about these often:
- Tobacco
- Animal Health
- Medical Foodstuffs
- OTC and OTC-switches
- Cosmetics
The good news is that several of our partners do work in these areas. You can find them HERE.
s, we offer a broad array of complementary services including Submission Publishing, Biometrics and Patent Research.
Awards & Recognition
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