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 ...

NEW YORK, Feb. 5 Intrasphere Technologies, a leadingconsulting firm that provides business-focused services and solutions to lifesciences organizations, announced today that the company's ...

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 ...

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) ...

The author describes several issues in creating drug master files and active substance files for active pharmaceutical ingredients and intermediates. This article covers the submission requirements ...