Gap Analysis and Successful submission of ANDA to USFDA

A pharmaceutical research and development company based in India was planning to submit ANDA to the USFDA within a short duration of time. Freyr had a short timeline for the projects and had several things to do. Freyr started with a detailed Gap Analysis to prepare the CTD sections of module 1, module 2 and module 3.

To know how the entire process was carried out under the Freyr’s expertise, read the case.

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