Reach Your End Goal with Facet’s FDA Regulatory Consulting Services

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 achieve success the first time, allowing you to get to market or complete a divestiture much faster.

Talk to the regulatory experts at Facet to make your asset’s first shot count.

Talk to the FDA experts about your science.

Comprehensive FDA Regulatory Services Tailored to the Needs of Emerging Biotechs

We help small to mid-size life sciences developers maximize the value of their assets at each stage, using innovative and aggressive regulatory strategies. Talk to our team of experts to advance your product through regulated development, secure regulatory milestones, and achieve your business goals.

US Agent

An experienced strategic liaison with US FDA on your behalf. Facilitates efficient collaboration and leverages decades of successful working relationships for your benefit.

Gap Analysis

Identify program gaps, risks and potential risk mitigation.

Strategic Regulatory & Development Guidance

Design and execute effective regulatory, CMC, nonclinical, and clinical strategies that support your end business goals.

Meeting with FDA

Using our rigorous preparation process, we make sure you’ve got strategic, well-written meeting documents and that you’re fully prepared to hold a successful meeting with FDA.

Medical Writing of Submission Documents

Facet will author and coordinate reviews for regulatory submissions on your behalf. We also review Sponsor submission documents for scientific integrity and regulatory compliance.

Regulatory Submission Leadership

We manage regulatory submissions creation, review and finalization for new drug/biologicals applications, medical device applications, and more!

Facet is Your Regulatory Pathmaker

“Facet helped our team achieve something unheard of. 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, Industry Expert and Investor

Why Choose Facet for FDA Regulatory Consulting?

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. 

Specialized
Expertise

We have over 300 years of combined experience guiding and supporting small companies in 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 work with you at your pace and provide high-impact, scalable services without the overhead of in-house staff.

Find Your Way To & Through FDA
Need help navigating? Our experts can help. Talk to us today about your specific needs.

Talk To FDA Experts