Integrated Solutions for Every Stage of Product Development

Facet builds defensible product pathways based on how regulators interpret data and how approval decisions get made, selecting endpoints that support your target label and identifying program risks before they become regulatory obstacles.

Our experts translate complex science into submissions regulators can act on, so your program advances through each milestone with fewer questions and less lost time.

U.S. Agent

Serve as designated FDA liaisons, ensuring traceable, ongoing communication between the agency and the sponsor

Gap Analysis

Identify program gaps before regulators or stakeholders do, and build a practical, cost-conscious risk mitigation plan

Strategic Regulatory & Development Guidance

Align early research with reviewer intent, and develop a coherent regulatory roadmap that fits production realities and market openings

Meeting with FDA

Prepare background packages and supporting materials that drive productive FDA interactions

Medical Writing of Submission Documents

Author and coordinate technically precise, submission-ready documents across all application types

Regulatory Submission Leadership

Own the full submission lifecycle — managing creation, QC, and finalization

Strategic Statistical Services

Design lean, efficient trials with statistical modeling and simulation to increase the probability of success in nonclinical and clinical trials

Powered by a diverse ecosystem of organizations, advisors, and solution providers, we offer a broad array of complementary services.

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
• Cosmetics

The good news is that several of our partners do work in these areas. You can find them HERE.

s, we offer a broad array of complementary services including Submission Publishing, Biometrics and Patent Research.