by Dr. Yashashwini Reddy | Apr 8, 2025
Various types of regulatory submissions are essential in the pharmaceutical and medical device industries. These include Investigational New Drug (IND) applications for clinical trials, New Drug Applications (NDAs) for new pharmaceuticals, Biologics License...
by Dr. Yashashwini Reddy | Apr 8, 2025
Regulatory Affairs professionals are responsible for ensuring that products and processes adhere to applicable regulations and standards, thereby protecting public health and safety. They collaborate with regulatory agencies, prepare and submit necessary applications,...
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 | Mar 30, 2025
Common Technical Document (CTD) for Regulatory Submission In the pharmaceutical industry, regulatory submissions are a crucial step in bringing new drugs to the market. One of the most widely accepted formats for regulatory submissions is the Common Technical Document...
by Dr. Yashashwini Reddy | Nov 27, 2024
Interview Questions and Answers for Drug Substance (3.2.S) in CTD – Regulatory Affairs (Freshers) 1. What is the role of 3.2.S in the CTD (Common Technical Document)? Answer: The 3.2.S section of the CTD is dedicated to the “Drug Substance,” which...
