The EMA has now reinforced its commitment to electronic submissions by mandating the use of the eCTD format for the centralized procedure of all electroniconly submissions. "From here on in, noneCTD ...

Finally the system can create the custom eCTD folder structure for your application. While eCTD Accelerator – Templates is the most cost effective template solution available, what makes it unique is ...

Background information eCTD format is the principal electronic submission format required by the European Medicines Agency (“EMA”) in the centralised market authorisation procedure since 2010.

This two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD.