by Naveen kumar | 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...
by Naveen kumar | Jun 4, 2024
In this article, you are going to learn about the regulatory procedure for combination products in the US. What is RFD what are the timelines for it and what role of the Office of Combination products? Combination products as discussed in the article are medicinal...
by Naveen kumar | May 24, 2024
Drug Regulatory Authorities of Different Countries Drug regulatory authorities play a vital role in enabling the safety, efficacy, and quality of medicine we take. These authorities involve in overseeing the development, testing, approval, and monitoring of drugs...
by Naveen kumar | May 6, 2024
Drug Master File In this article, we are going to learn about DMF and types of drug master files etc. By the end of this article you are going to the requirement of DMF in regulatory submission i.e. its purpose and also the contents of each drug master file Always...
