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 ...
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 ...
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 ...
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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 European Medicines Agency (EMEA) has set a timetable for the implementation of electronic-only applications for marketing authorisation through the centralised approvals procedure. The European ...
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 ...
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