SCIENTIFIC & REGULATORY DEVELOPMENT FOR SMALLER LIFE SCIENCE COMPANIES

Home2023-02-22T15:15:16+00:00

SCIENTIFIC AND REGULATORY EXPERTISE TO GET YOU TO AND THROUGH THE FDA

The results of successful R&D efforts in the life sciences industry tell a story about a drug, biologic, medical device, or combination product. The challenge for every organization is: how do you develop and tell the story? Facet Life Sciences can partner with you to determine your path to write your own best seller.

FDA Meetings2023-03-08T14:08:56+00:00
Regulatory Assets2023-03-02T19:32:28+00:00

Breakthrough Designation
Fast Track Designation
Orphan Designation
Rare Diseases Voucher
Special Protocol Assessment
Tropical Diseases Voucher

Dosage Form Experience2023-03-02T19:36:00+00:00

Capsules
Creams
Gels
Liposomes
Medical Gases
Microdose Powders
Monoclonal Antibodies
Parenterals (liquid lyophilized)
Parenterals (powder fill)
Overencapsulation
Patches
Powders
Synthetic and Semi-synthetic Drug Substances
Tablets (IR and ER)
Toothpaste
Suppositories
Swabs
Vaccines

Therapeutic Area Experience2023-03-02T19:34:05+00:00

Allergy
Cardiovascular/Renal
Dermatology
Diagnostic and Therapeutic Radiopharmaceuticals
GI
Immunology
Infectious Disease
Neurology
Oncology
Ophthalmology
Pain
Psychedelics
Psychiatry
Reproductive Health
Ultra-Rare Diseases

Application Type Experience2023-03-02T19:34:46+00:00

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

Facet leverages our strong scientific, development, and regulatory expertise to help create success stories- page by page, chapter by chapter. For more than 10 years, we have helped many organizations reach successful outcomes, from concept to commercialization, and beyond.

Development Solutions for Small Teams with Big Goals

At Facet, we believe traditional (i.e., large pharma/big CRO) models for product development don’t align with the needs and capabilities of today’s more nimble emerging developers.

Facet’s aggressive and entrepreneurial development approach can help you formulate an effective development plan and strategies that are right for your company and product.  We then execute on that plan side-by-side, step by step, with you and your other partners. 

Our team of experts have decades of practical experience and routinely interact with the FDA on behalf of our clients.  We bring product development, nonclinical, clinical, CMC and regulatory expertise to tell your development story to FDA.  

SUCCESSFULLY PROVIDE EXPERT GUIDANCE AND PRACTICAL TOOLS

INNOVATIVE REGULATORY STRATEGIES FOR YOUR VALUABLE ASSET

BROAD THERAPEUTIC AREA EXPERIENCE

EXTENSIVE DOSAGE FORM EXPERIENCE

Your goals are our goals and your success is our success.

This mindset drives every aspect of our relationships with clients.

Facet proactively worked with us and FDA to design and implement a Phase 3 program that was manageable for a small company to conduct.  Facet was a critical part of our NDA application strategy and used their expertise to author, finalize, submit, and shepherd our combination product NDA through the FDA review process.  We’re excited about our pending NDA decision from FDA.

Ken West, Board member and former CEO

“Facet’s innovative strategies got us to an open IND faster than we expected.  What’s more, their dynamic approach and excellent working relationship with the FDA has us well positioned to progress our unique disease-modifying therapy.”

Marc Gleeson

Facet helped our team achieve something unheard of in the psychedelics industry.  Their strategic leadership and flawless tactical execution supported us from conception to successful IND-filing for a new chemical entity in 18 months.”

Michael Palfreyman, Ph.D.

Facet took us from pivotal study database lock to NDA (approved) in six weeks.” 

Small Pharma CEO

No one is great at everything.  We pride ourselves on partnering with other great organizations that can help you.  We have long-term relationships with boutique nonclinical and clinical CROs, contract manufacturers, statisticians, auditors, patent attorneys, regulatory submission publishers, just to name a few!

Facet’s team of experts routinely interact with the FDA on behalf of clients, bringing nonclinical, clinical, CMC and regulatory expertise to drive development efforts. We help formulate effective development plans with strategies to execute on those plans.  Your goals are our goals and your success is our success.  This mindset drives our partnerships with clients.

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