by Dr. Yashashwini Reddy | Mar 30, 2025
Module 3: Quality (CMC) in Regulatory Dossier Submission In pharmaceutical regulatory submissions, Module 3 of the Common Technical Document (CTD) plays a critical role in ensuring drug quality, safety, and efficacy. This module, also known as the Quality Module,...
by Dr. Yashashwini Reddy | Nov 13, 2024
In the world of pharmaceuticals, Active Pharmaceutical Ingredients (APIs) and Intermediates are essential yet distinct parts of the drug manufacturing process. Understanding Active Pharmaceutical Ingredients (APIs) An API is the core component of a drug, directly...
by Dr. Yashashwini Reddy | 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...
