Performed Gap Analysis and Successful Submission of ANDA to the USFDA

The client is an U.S. based generic pharmaceutical company that was looking forward for a successful submission of ANDA to the USFDA. Freyr having an expertise in preparing CTD sections and submission of ANDA completed the project in 3 phases. Freyr provided detailed Gap Analysis for the product and successfully submitted the ANDA to the USFDA.

Read this case how Freyr was able to mitigate RTR by submitting 7.5 months stability data for accelerated and long-term stability condition.

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