The client was a USA-based global leader in the generics industry and was looking for Regulatory support in ANDAs, supplements, and PADER submissions. The project presented challenges such as reviewing and filing all the study documents within stringent timelines and per the US FDA regulations. 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 multiple challenges and delivered end-to-end Regulatory services to the client by creating, reviewing, and filing high-quality ANDA and PADER submissions with zero deficiencies. Download the proven case.