FDA Regulatory Consulting Services
Drug, Biologic, Device, and Combination Product Development is Expensive & Risky.
Give your asset the best shot at progressing to and through FDA by partnering with our dedicated FDA Regulatory Consulting team. We help you navigate regulatory challenges and find success the first time, allowing you to get to market or divestiture much faster.
MAKE YOUR FIRST SHOT COUNT
A Different Approach to Regulatory Affairs
At Facet Life Sciences, we see regulatory affairs very differently than other organizations do. The standard approach feels closed off and rigid. “No, you can’t do that” is a phrase that is commonly used and we push back on that.
While others in the industry operate conservatively and aren’t looking to push the envelope, we take an aggressive, innovative, data-driven, and strategic stance when it comes to regulatory affairs. Time and time again, this approach has led to consistent success for our clients.
Want to see what we mean? Give us a shout and we’ll show you.
Regulated product development is not only expensive, it can also be daunting. The importance of a small or mid-sized company getting it right the first time cannot be understated. Traditional “large pharma” approaches can hold your asset back from moving forward for months, if not years, and waste millions of dollars.
At Facet Life Sciences, we help small to mid-size life sciences developers maximize the value of their assets at each stage. We do this using innovative and aggressive regulatory strategies and flawless execution. We have a proven track record of success helping to streamline development and successfully navigate products through FDA. Let our team of regulatory experts help you to advance your product in regulated development, secure regulatory milestones, and achieve your business goals.
Our Comprehensive FDA Regulatory Services Include:
We provide fully integrated solutions for small organizations through partnerships. Our carefully selected partners work with small businesses in the same way that Facet does and can assist you with:
- Patents
- Manufacturing (CDMO Services)
- Nonclinical study execution
- Phase 1-4 clinical trial
- Contract medical monitoring
- CDISC, ADaM, and SEND data packages
- Submission publishing
- Ex-US regulatory support
We’ve Just About Seen It All
We Work With Virtually Every Application Type,
Every Therapeautic Area,
And Almost Every Dosage Form.
Here’s the Shortlist of Rare Exceptions.
WHY CHOOSE FACET LIFE SCIENCES?
Your Success is Our Mission
At Facet, your success drives us. We form lasting partnerships, offering the expertise and tools needed to bring your product to divestiture or to market successfully. Join the many companies that have turned their innovative ideas into reality with Facet Life Sciences.
Specialized Expertise
We have over 300 years of combined experience guiding and supporting small companies into successfully divesting or commercializing their products.
Tailored Solutions
Not all companies are the same. We develop custom strategies to ensure long term success for our clients that address their unique challenges and opportunities.
Cost-Effective Partnership
We provide high-impact, scalable services without the overhead of in-house staff.
Client Success Stories
"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."
"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."
"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."
"Facet took us from pivotal study database lock to NDA (approved) in six weeks."
Ready to Partner with the Best Regulatory Team?
Your company and your product deserves the best support. Contact us today to schedule a consultation and learn how our regulatory services can align your strategy for success.
Learn More About Our Unique Approach
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