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 26, 2024
Interview Questions on Common Technical Document (CTD) for Regulatory Affairs Freshers 1. What is the Common Technical Document (CTD)? Answer: CTD is a standardized format for submitting regulatory documents for drug approvals. It simplifies the submission process...
by Dr. Yashashwini Reddy | Nov 26, 2024
Interview Questions and Answers for Regulatory Affairs Freshers 1. What is Regulatory Affairs? Answer: Regulatory Affairs involves ensuring that pharmaceutical products comply with regulations and laws concerning drug development, registration, and marketing. It acts...
by Dr. Yashashwini Reddy | Nov 25, 2024
Forced Degradation Studies in Pharmaceuticals Introduction Forced degradation studies are essential in the pharmaceutical industry for evaluating the stability of drug substances and formulations. These studies involve exposing drugs to extreme environmental...
by Dr. Yashashwini Reddy | Nov 21, 2024
What is Analytical Validation? Why Is It Done? Analytical validation is a vital process in the pharmaceutical industry, ensuring the methods used for drug analysis are accurate, reliable, and consistent. By validating analytical methods, pharmaceutical companies...
