A U.S. based fortune 500 global technology and specialty material company approached Freyr to perform Gap Analysis and support with Regulatory strategy and preparation of response to the USFDA queries for DMFs. Freyr started with evaluation of the FDA query and supporting documents shared by the clients and later worked on preparation of strategy and response to the FDA queries.
How did Freyr manage all this in just 30 business days before submitting the response to the USFDA? Read the case.
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