The Facet Life Sciences Services Team is made up of outside the box thinkers, passionate strategists, and highly experienced development experts and though we don’t look like classic heroes, we have saved the day for our clients a time or two. Our superpowers include a practical and honest approach, strategic and regulatory guidance, regulatory submission leadership, gap analysis, chemistry manufacturing and controls and getting our clients successfully through FDA meetings. We view business challenges as catalysts that spark innovation. Our customers’ goals are our priorities and fuel our efforts to create novel solutions that streamline R&D practices.
The Facet Life Sciences Services Team is comprised of development, regulatory affairs, and regulatory writing experts who have advanced scientific degrees and hundreds of years of experience in the pharmaceutical, biologics, biopharmaceutical, and/or device industry. All staff have worked for both large and small companies, so each expert brings the knowledge and experience of a large organization with the skills and mindset of a small and nimble innovator company to add unique value to every project.
We offer the following flagship services
Through our partners, we offer a broad array of complementary services including Submission Publishing, Biometrics and Patent Research.
Our 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
Allergy
Cardiovascular/Renal
Dermatology
Diagnostic and Therapeutic Radiopharmaceuticals
GI
Immunology
Infectious Disease
Neurology
Oncology
Ophthalmology
Pain
Psychiatry
Reproductive Health
Ultra-rare Diseases
Identify program gaps, risks and potential risk mitigation
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
The good news is that several of our partners do work in these areas. You can find them HERE.
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