Facet Life Sciences

An objective evaluation of a product in the context of a company’s stated goal, identifying gaps from development, medical, regulatory, and commercial perspectives and suggesting potential risk mitigation.

Generation or review of a carefully designed strategic and tactical regulatory plan covering clinical, nonclinical, CMC, and procedural activities to meet specific corporate goals.

A strategic and tactical process facilitating FDA meeting success, including recommending meeting timing, type, format, authoring meeting requests and background packages, rehearsals, and meeting roles.

Facet Life Sciences offers regulatory and development consulting services to support rare disease drug development, including FDA submission process guidance and leveraging regulatory pathways for rare and ultra-rare diseases.

Strategic and tactical team leadership managing regulatory submission projects from inception to FDA submission, including new drug/biologics applications, medical device applications, and special regulatory designations.

Improve R&D decision-making with asset valuation insights, then translate that science into market-ready language.

An experienced strategic liaison with US FDA on your behalf, facilitating efficient collaboration and providing strategic and tactical support for all types of FDA meetings with CDER, CBER, and CDRH.

Experienced regulatory medical writers author, QC/format, and finalize documents for US IND, IDE, NDA, BLA, or device applications, including FDA meeting requests, protocols, study reports, and labeling.

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

Advanced statistical consulting services to guide and accelerate drug, biologics, medical device, and combination product development using innovative study designs and analytic techniques.

Gemstone is an electronic document management solution designed for small biopharmaceutical teams, providing a simple, secure, and compliant tool to manage complex development document lifecycles.