A US-based, leading generics pharmaceutical company reached out to Freyr for Regulatory assistance in the compilation and submission of the PAS to the USFDA. The scope of the project included the compilation and evaluation of the documents to facilitate the submission to the Agency. Freyr’s Regulatory Affairs (RA) team had to work against time to conduct a gap analysis of all the documents and create them per the FDA’s requirements.

Learn how Freyr's Regulatory Affairs (RA) team was able to submit the PAS to the US FDA under the given timeframe by evaluating and compiling the documents and working collaboratively with multiple stakeholders. Download the proven case.