A REGULATORY PATHMAKER FOR EMERGING BIOTECH
Create a viable route toward FDA and market acceptance with Facet – the regulatory affairs and product development strategy partner for small biotech and emerging science.
LET'S TALK ABOUT YOUR PATH
Transforming Scientific Innovation into Regulatory Readiness
Facet Life Sciences helps small life science companies navigate drug, biologic, and medical device development with precision and expertise. We specialize in charting entrepreneurial, successful FDA regulatory pathways for novel and complex innovations. We guide you to and through the FDA, so you can get your products to patients in need.
Custom Solutions for Every Stage of Product Development
With decades of experience in product development, nonclinical, clinical, CMC, regulatory affairs, and commercial launch, our experts are ready to support your unique goals and lead every stage of your process from early regulatory planning to meeting preparation and submission leadership.
Ensure your evidence is clear, your rationale is defensible, and your interactions with the FDA are well-reasoned and productive.
Where Are You On Your Journey?
For over a decade, Facet has been helping organizations reach successful FDA and commercial outcomes.
Discovery
PRE-IND/
Q-Sub
MTG
Clinical
Research
Launch/
Marketing
Preclinical
Research
IND/
IDE
Marketing
Application
Expert Regulatory Solutions
Regulatory Services
Aggressive, scientifically sound progress to development and regulatory milestones. Strategies aligned with your resources and business objectives.
Medical Writing
Clear, concise, and accurate presentation of nonclinical, CMC, and clinical data, written with the FDA reviewer in mind.
Strategic Statistical Services
Using biometrics to develop lean and efficient nonclinical and clinical trial designs. Improve effectiveness and increase the probabilities of success.
Asset Valuation and Optimization
Understand your asset value and learn how to improve it through your R&D efforts. Translate your science into product value and answers to investor or partner questions.
Bring Complex Innovations to Market With Full-Lifecycle Regulatory Support
At Facet, we know how FDA reviewers interpret data, how decisions are made, and how to prepare submissions that withstand scrutiny.
We also know that traditional development models built for large pharma and major CROs often don’t fit the needs of today’s nimble emerging companies.
That’s why we develop strategies tailored to your product, resources, and goals — and execute them alongside you and our partners, step by step, as a true extension of your team.
Regulatory Services
Hundreds of years of combined experience working directly with FDA to ensure your interactions are productive and submissions are thorough, well-prepared, and on target.
R&D and Asset Valuation Strategies
We develop customized regulatory, statistics, and asset value strategies to accelerate your plans and maximize your success.
Broad Therapeutic Experience
Our knowledge spans all therapeutic areas and most dosage forms, providing comprehensive support.
WHY CHOOSE FACET LIFE SCIENCES?
Your Regulatory 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 market successfully. Join the many companies that have turned their innovative ideas into reality with Facet Life Sciences.
Client Success Stories
Awards & Recognition
Let’s Maximize Your Submission Window
Your company and your product deserve a strategic regulatory partner. Contact Facet Life Sciences to learn how we can help you reach your goals.
LEARN MORE ABOUT OUR UNIQUE APPROACH
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