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...
by Dr. Yashashwini Reddy | Nov 27, 2024
Interview Questions and Answers on Module 3.2.P (Drug Product) Under Quality – CTD 1. What is the 3.2.P section of the CTD? Answer: The 3.2.P section in Module 3 of the CTD deals with the drug product. It provides detailed information about the finished dosage...
by Dr. Yashashwini Reddy | Nov 27, 2024
1. What is the New Drug Approval (NDA) process? Answer: The NDA process is the regulatory pathway for approving a new drug for marketing. It ensures the drug is safe, effective, and of high quality for its intended use. In the U.S., the FDA evaluates the data...
