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 ...
Dublin, Nov. 03, 2022 (GLOBE NEWSWIRE) -- The "Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course" conference has been added to ...
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 ...
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 ...
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Drug approval is the goal of the long process of drug development. Once preclinical and clinical trial data have been collected, a New Drug Application must be submitted to the regulatory authority ...
Dublin, May 19, 2025 (GLOBE NEWSWIRE) -- The "Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course" training has been added to ...
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 ...
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