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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...

Sharan Murugan
May 25, 20242 min read
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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...

Sharan Murugan
Aug 12, 20221 min read
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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...

Sharan Murugan
Sep 5, 20211 min read
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