What is Trial Master File ?

A Trial Master File is a collection of documents in an organized way, and it ensures clinical trials are conducted as per good clinical practices following regulatory requirements. TMF is very important in ensuring that the trial has been managed successfully by the...

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...

DMF submission Process

Drug Master File Submission Process We have discussed the types of drug master files and their purpose in the previous article now we will learn how a DMF is submitted to the FDA in short. Procedure for DMF submission Electronic Common Technical Document (eCTD): DMFs...

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