What is the Common Technical Document (CTD)?

Common Technical Document (CTD) for Regulatory Submission In the pharmaceutical industry, regulatory submissions are a crucial step in bringing new drugs to the market. One of the most widely accepted formats for regulatory submissions is the Common Technical Document...

DMF submission Process

Drug Master File Submission Process We have discussed the types of drug master files and their purpose in the previous article now we will learn how a DMF is submitted to the FDA in short. Procedure for DMF submission Electronic Common Technical Document (eCTD): DMFs...

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