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 ...

The eCTD is rapidly moving towards the preferred, and in some cases mandated, electronic submission format world-wide. As of January 1st of this year, FDA mandated the eCTD format for all ...

Regulators at Health Canada have announced the finalization of guidance intended to assist sponsors in preparing electronic common technical documents (eCTDs) to submit their pharmaceutical dossiers ...

After years of transitioning in the requirement for drug and biologics sponsors to submit applications to the U.S. FDA in the electrical common technical document format (eCTD), the agency is getting ...

This two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other ...

The original deadline for submitting Type III DMFs in eCTD format was May 5, 2017; however, that deadline was extended for an additional 12 months and subsequently pushed back again to May 5, 2020 ...

WARNER ROBINS, Ga. , Oct. 21, 2014 /PRNewswire/ — Today in Atlanta, GA , Aquila Solutions, LLC announced the immediate availability of eCTD Accelerator – Templates, enabling sponsors and consultants ...