The client was USA-based research and technology-based pharmaceutical company looking for Regulatory support in the successful filing of original applications, PADER, promotional labeling, amendment responses, requests, and correspondence with the USFDA. The project demanded a resource pool that could work on ad hoc submission requests in stringent timelines and maintain the lifecycle activities for multiple products. Freyr guided the client and filed the submissions with zero errors per the USFDA requirements. Freyr deployed multiple resources to meet the compliance and business objectives of the client.
Decode how Freyr overcame the obstacles and filed multiple submissions for the original applications and helped in the lifecycle maintenance of several products. Download the proven case.