Case Study: a pharma giant clarifies FDA requirements for a complex generic injectable product with FREYR

a pharma giant secures FDA Written Responses Only with FREYR

The Italy-based pharmaceutical company, a pharma giant, faced significant regulatory challenges in developing a complex generic injectable product for the US market. They lacked clarity on the US FDA's expectations, particularly regarding bioequivalence studies and product specifications. The vendor, FREYR, was engaged to provide comprehensive regulatory support and devise a strategy for engaging with the agency.

FREYR successfully facilitated a product development meeting (PDM) with the US FDA by preparing a thorough meeting package and providing specific regulatory guidance. As a result, the FDA granted the meeting and provided written responses that clarified all of the client's development concerns. This successful engagement by FREYR ensured regulatory compliance and facilitated smooth proceedings for the complex generic product's development.