The Facet Life Sciences services team is comprised of development, regulatory affairs, and regulatory writing experts who have advanced scientific degrees and hundreds of years of experience in the pharmaceutical, biologics, biopharmaceutical, and/or device industry. All staff have worked for both large and small companies, so each expert brings the knowledge and experience of a large organization with the skills and mindset of a small and nimble innovator company to add unique value to every project.

We offer the following flagship services

U.S. Agent

Primary role is to communicate directly with US FDA on behalf of a sponsor. For companies that do not have a US presence, a US Agent is required to bring investigational or marketed product into the US. For companies that have a US presence, a contract US agent is desirable when regulatory expertise is not available in house or resources are limited.

Gap Analysis

An objective evaluation of a product in the context of a company’s stated goal (e.g., NDA submission). The gap analysis is a strategic evaluation from a development, medical, regulatory, and commercial perspective. Gaps are identified and potential risk mitigation is provided. Timelines and estimated costs to the stated goal are included.

Strategic Regulatory and Development Guidance

Generation and review of a carefully designed regulatory plan (clinical, nonclinical, CMC and procedural activities) that must be accomplished to meet a specific corporate goal for a company’s product.

Medical Writing of Submission Documents

Authoring and coordination of cross-functional reviews for regulatory submission documents including competitive product labeling content and risk management in the context of the current market landscape, US regulations, and guidances for that product.

Regulatory and Scientific Review of Submission Documents

A detailed review of the scientific basis and regulatory compliance of submission content.

Regulatory Submission Leadership

Management of the creation, review and finalization of regulatory submissions (e.g., INDs, NDAs/BLAs).

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

Download Our Brochure of Services for More Details