The client was a USA-based generic drug manufacturer and was looking for Regulatory support for the submission of Q2 PADER to the FDA. Freyr did a complete review of the PADER content in a short period and was able to submit the report in a compliant manner. Freyr evaluated the documents and prepared the cover letter and the report amid challenging circumstances. The PADER was supported by the relevant technical documents and Freyr followed all the Regulatory guidelines to enable the client to meet their business goals with the help of the right resources.
Find out how Freyr was able to submit the Q2 PADER on time and in line with the Regulatory requirements of the USFDA. Download the proven case.