Electronic Common Technical Document (eCTD)

The Electronic Common Technical Document, or eCTD, is the standard format for all applications, amendments, supplements, and reports that need to be sent to the FDA's Center for Drug Evaluation and Research or their Center for Biologics Evaluation and Research.  An Addis Pharma consultant can support your Regulatory team with these critical filings should you need assistance.

Important eCTD updates can be found on the FDA's website (Click Here)