The client was a USA-based leading generics manufacturer and was looking for Regulatory support in original ANDAs, supplements, and PADER submissions. The project presented challenges such as reviewing and filing high-quality submissions in stringent timelines. With an experienced resource pool, Freyr was able to provide end-to-end publishing support by reviewing the study documents, coordinating with the CRO, and making the final ESG submissions. With zero errors and over 70% cost benefits, the client was able to meet all the compliance and business requirements, respectively.
Decode how Freyr addressed the challenges and delivered end-to-end Regulatory services to the client by creating, reviewing, and filing high-quality ANDA and PADER submissions in a short period. Download the proven case.