CGT Request Preparation and Submission to the US FDA

An US-based active pharmaceutical ingredients manufacturer required Regulatory assistance in compilation of section and update, gap analysis of technical documents, finalization, and submission of Competitive Generic Therapies (CGT) request. An Abbreviated New Drug Application (ANDA) is requested, despite several challenges, such as lack of awareness of the USFDA's CGT Regulatory requirements per FDA procedures. Freyr was effective in providing the strategic inputs on CGT requirements and determination of CGT qualification.

Explore how Freyr contributed to delivering updated and finalized CGT request as per the current FDA requirements.