A UK-based, leading multinational generics pharmaceutical company approached Freyr for Regulatory assistance in the submission of the PAS to the USFDA. The challenge was to review the PAS content provided by the customer, identify the gaps, and work with multiple stakeholders to finalize and file the submission within the given timeframe.

Freyr, with the help of the Regulatory Affairs (RA) team, understood the Regulatory guidelines and helped the customer maintain their business objectives with a compliant strategy. 

Download the proven case to fully comprehend how Freyr's RA team was able to file the PAS to the USFDA within the given timeframe by thoroughly evaluating the documents and compiling them for submission.