Comprehensive Gap Analysis and Successful Submission to the USFDA

The client is a $600+Mn pharmaceutical company based in South Korea, which approached Freyr for the review of the raw data, impact analysis of the changes, compilation of the affected sections including administrative documents and submission to USFDA. With short delivery time Freyr was able to provide timely review of the raw data as and when received from the client and performed the complete Gap Analysis.

To read the details of the project, go through the case.

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