Services to Ease FDA Regulatory Compliance

Tag Archives: eCTD

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

From the beginning of  May 5, 2017,  FDA requires, ANDA, NDA, and Master Files regulatory submission in eCTD format. Link to FDA’s eCTD submission requirements 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 … Continue reading FDA’s Mandatory eCTD requirements ? Are you ready ?

Translate »