CTD- Common Technical Document

The Common technical document has 5 modules and is a format set by ICH for assembling the quality, safety, and efficacy information in a common format. The CTD document was introduced to streamline the dossier submission process as the earlier process was not uniform...

“How to Get Marketing Authorization in Europe”

In this article, you are going to learn about the marketing authorization process in the EU region. European Medicines Agency (EMA) is the key regulator for regulating and monitoring medicinal products in the European Union. It has some expert committees which provide...

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