A USA-focused, growth-oriented, specialty pharmaceutical company was looking for Regulatory support in ad hoc submissions creation and filing to the USFDA. The client’s project presented several challenges, such as stringent deadlines, maintaining the lifecycles of all their products, and coordinating with the CMC team for published documents. Freyr’s team addressed all the challenges and filed the submissions with zero errors and warnings. The client was able to file quality NDA-PADER, CMC, and General Correspondence submissions.

Know more about how Freyr helped the client meet their business requirements in defined timelines and ensured the filing of ad hoc submissions to the US FDA with zero errors. Download the proven case.