by Dr. Yashashwini Reddy | Jun 5, 2024
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...
by Dr. Yashashwini Reddy | Jun 4, 2024
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...
