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FDA’s Mandatory eCTD requirements ? Are you ready ? February 25, 2017

eCTD ! From the beginning of  May 5, 2017,  FDA requires, ANDA, NDA, and Master Files regulatory submission in eCTD  format. Since FDA is mandating electronic submission  requirements from May 5, 2017 for all the  future amendments, annual reports , supplements or any such regulatory filings. But, its not mandatory to convert all previous submission in electronic format. … Continue reading FDA’s Mandatory eCTD requirements ? Are you ready ?

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