by Dr. Yashashwini Reddy | Apr 19, 2025
1. What are stability studies and why are they important? Stability studies determine how the quality of a drug substance or product varies over time under the influence of environmental factors (e.g., temperature, humidity, light). They are essential for setting...
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 26, 2024
Top Interview Questions for Experienced Candidates in Formulation R&D (Oral Solid Dosage) 1. Can you explain the pre-formulation studies conducted before developing an OSD? Answer: Pre-formulation studies involve evaluating the physicochemical properties of a drug...
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...
by Dr. Yashashwini Reddy | Sep 29, 2024
“Essential Regulatory Affairs Interview Questions for Freshers in Pharma: Tips & Answers” 1. What is an Abbreviated New Drug Application (ANDA)? Answer: An Abbreviated New Drug Application (ANDA) is a regulatory submission to gain approval for a...
