Compilation, Evaluation, and Submission of Annual Report to the USFDA

A US-based, leading generics pharmaceuticals company was looking for Regulatory support in the compilation, evaluation, and submission of an Annual Report to the USFDA for their product compliance. The project presented various challenges such as reviewing documents within stringent timelines, performing gap analysis, and resolving them to meet the FDA requirements. Freyr’s team updated the documents and ensured compliance by filing the submission within the due date.

Comprehend Freyr’s expertise in fulfilling the customer’s business requirements and ensuring product continuity in the US market. Download the proven case.

Fill the form below to download the Case Study