The client was a USA-based pharmaceutical company and was looking for support in the submission of response to FDA query on transfer of ANDA ownership in line with the USFDA requirements. The project presented several challenges such as lack of resources to handle the administrative changes and a short-time period for the submission. Freyr conducted an in-depth gap-analysis of the document and was able to update the cover letter and Form 365H in the agreed timelines. Freyr followed a compliant Regulatory pathway and supported the client in responding to the query and reviewing the final package.
Find out how Freyr addressed the challenges and supported the client in submitting the response per the USFDA guidelines. Download the proven case..