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Sharan Murugan
May 252 min read
EDQM Guidance: Content of the Dossier for Sterile Substances
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released a draft guideline titled "Content of the Dossier...
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Sharan Murugan
Aug 12, 20221 min read
Europe's EDQM: Nitrosamines – Deadline Extension for all CEP Holders - Now 1 October 2023
Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. EU regulators first became...
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Sharan Murugan
Sep 5, 20211 min read
Updated Guidance for e-Submissions for CEP applications
As the eCTD format is mandatory for the submission of all applications for Certificates of Suitability to the monographs of the European...
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