DID YOU KNOW?
- 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.