The client was a USA-based generic drug manufacturer and was looking for Regulatory support in the submission of the PADER to the FDA. Freyr reviewed the PADER content provided by the client and evaluated the technical documents within stringent timelines. Freyr submitted the report along with the cover letter to the FDA with the help of the best talent pool that understood the relevant Regulatory guidelines and helped maintain the business objectives with a compliant strategy.

Know more about how Freyr was able to submit the PADER on time by evaluating and compiling the technical documents using the ideal Regulatory pathway. Download the proven case.