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Regulatory
Vighnsolution helps in the Review of the all three types of DMFs as per FDA guidelines
01
The Review of Drug Master Files – USFDA, EDQM, EU GMP, etc in CTD Format
02
Module-1 (Administrative & Prescribing Region-Specific information)
03
Module-2 (Quality Overall Summary)
04
Module-3 (Quality)
05
Review, and Filling Changes to the Registered Documents
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