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 | May 17, 2024
In this article, we are going to learn the concept of process validation in concise . Validation is an act of proving right with documented evidence, suppose you create a new password, and the system to validate your password, asks you to re-enter so that you are...
by Naveen kumar | May 5, 2024
Active Substance Master File also known as European Drug Master File allows the protection of confidential information regarding the ” know-how of the active substance manufacturer”. While protecting the intellectual property information ASMF equips the...
