CTD

Marketing Authorization Approval Process in Europe

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Marketing Authorization Approval Process in Europe showing EMA review, CTD dossier submission, scientific assessment, and approval workflow.

Marketing Authorization Approval Process in Europe | Complete Guide to EU Pharmaceutical Registration Marketing Authorization Approval Process in Europe: Complete Regulatory Guide Obtaining a Marketing Authorization (MA) is one of the most important milestones in bringing a pharmaceutical product to the European market. Before any medicinal product can be marketed within the European Union (EU) … Read more

QUALITY by DESIGN (QbD)

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WHAT IS QUALITY BY DESIGN? “You can’t test quality into drug products” has been heard for decades – so what’s new? ICH Q8 Pharmaceutical Development focuses on the content of the Module 3.2.P.2 of the Common Technical Document (CTD) and promotes the concept of QbD. It supports knowledge gained through the lifecycle of a product … Read more