Facet only works with smaller life sciences companies, academic institutions, or nonprofit organizations to help get their products to and through FDA
Facet was regulatory lead for two US marketing approvals in 2022 – 1 new chemical entity and 1 505(b)(2) product
Facet helps organizations determine a sound, streamlined development plan which outlines the necessary nonclinical, CMC, and clinical information needed to achieve a specific regulatory milestone. For some organizations, this means IND green light, for other organizations, it means taking a product “all the way” to marketing approval.
Facet regularly meets with FDA to discuss drug and biological product development both in formal and informal meetings.