Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format ...

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 ...

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) ...

DUBLIN--(BUSINESS WIRE)--The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering. This two day workshop will provide you ...

DUBLIN--(BUSINESS WIRE)--The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering. The international agreement to assemble ...

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 ...

Joshua Boutwell, President and CEO of Aquila Solutions said, “We are pleased that our expertise in eCTD authoring is now available to everyone. We know our eCTD Templates will help sponsors save time ...

An IND application submitted to the FDA can easily run 10 or more volumes, largely consisting of reviews and copies of published studies related to the drug in question. Many of the required documents ...

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 ...