A US-based, leading generics pharmaceuticals company was looking for Regulatory support in the submission of the PADER to the USFDA. The project came with multiple challenges such as compiling, evaluating, and submitting the PADER within stringent timelines to avoid non-compliance. Freyr’s team reviewed the documents received from the customer and performed a gap analysis to identify and resolve the discrepancies. Freyr was able to file the submission by validating the documents and sending them to the Agency before the due date.
Explore how Freyr offered Regulatory support to the client in the submission of the PADER to the USFDA within defined timelines. Download the proven case.