End-to-End Gap Analysis with Submission of ANDA to the USFDA

The client is a generic pharmaceutical company located in USA. The client consulted Freyr to prepare ANDA and submit it to the USFDA. Freyr initially did an end-to-end Gap Analysis, prepared the CTD sections, and successfully submitted the ANDA to the USFDA. Freyr was able to mitigate RTR risk by submitting 7.5 months stability data for accelerated and long-term stability condition.

Although Freyr had a major challenge of coordinating with multiple stakeholders for finalization of source documents, Freyr achieved the desired results. How? Read the case