Your Regulatory Pathmaker for Emerging Biotech

Facet works where the path isn’t obvious. We plan and execute the strategic, scientific, and regulatory steps that move novel therapies toward FDA engagement. We’re here to create viable approval paths for emerging therapeutics, particularly when precedent is limited or frameworks are thin.

Let’s sit down for a 30-minute expert-led regulator strategy session, where we’ll discuss:

  • Your science, your goals, and how far you want to take it all.
  • A high-level view of regulatory strategies and options for viable paths forward.
  • How the Facet team can support you at every stage of the submission.

Book your 30-minute regulatory strategy session.

Strategy and execution that accelerates novel therapies to and through the FDA

Facet provides strategic planning, medical writing, data integration, gap analysis, and submission leadership for every stage of development. Everything from pre-IND packages and meeting requests to marketing applications and post-submission support.

Regulatory Services

Give your novel ophthalmology therapy the best shot at progressing to and through the FDA. Get aggressive, scientifically sound progress towards your development and regulatory milestones. Our strategies align with your resources and business objectives.

Medical Writing

Facet offers clear, concise, and accurate presentation of nonclinical, CMC, and clinical data, written with the FDA reviewer in mind. For sponsors who choose to author their own documents, we provide expert-level reviews focused on scientific integrity, completeness, and regulatory compliance.

Strategic Statistical Services

Improve effectiveness and increase the probabilities of success with our statistical services. From innovative study designs to cutting-edge analytic techniques, our strategic statistical consultants help small teams do more with less.

Asset Valuation and Optimization

Save time and money by knowing your asset's value and how to improve it through your R&D efforts. Translate your science into product value and answers to investor or partner questions.

Facet is Your Regulatory Pathmaker

"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."

BOARD MEMBER AND FORMER CEO Ken West

Book a 30-Minute
Regulatory Strategy Session

Start uncovering your approvable path forward with Facet. Book your strategy session today.