All regions that have published guidelines will mandate implementation of eCTD version 4.0 by 2028, with more regions to follow in the future Developed by the International Council for Harmonisation ...

How to cut time and cost by re-using already submitted documents. Increasing drug-development costs, patent expirations, and fewer blockbuster drugs in the pipeline are forcing life-science companies ...

In 2005, the heads of the European medicines agencies agreed that all EU member states must have the infrastructure and processes in place to handle only electronic Common Technical Document (eCTD) ...

An initial marketing application submission is a major undertaking that requires a large team, numerous tools and a litany of subprocesses to work together in harmony for a successful outcome. Leaving ...

Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "eCTD Submissions - Fundamentals and Process" training has been added to ResearchAndMarkets.com's offering. eCTD Submissions, or electronic Common ...

The U.S. Army Medical Research and Materiel Command's Enterprise Information Technology Project Management Office helped the U.S. Army Medical Materiel Development Activity submit its first in-house ...

Celegence, a global provider of regulatory affairs services and solutions for the life sciences industry has added new functionality to Dossplorer™, its advanced, cloud-based dossier management ...

With an approaching deadline of 1 January 2019, Health Canada is requesting industry input on establishing mandatory requirements for submitting drug master files (DMFs) using the electronic common ...

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 ...

DUBLIN--(BUSINESS WIRE)--The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" webinar has been added to ResearchAndMarkets.com's offering. This four day webinar series (each day 3 ...