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 | Dec 1, 2024
Classification of GMP Deficiencies: A Comprehensive Guide for Pharmaceutical Compliance Good Manufacturing Practice (GMP) is a cornerstone of pharmaceutical manufacturing, ensuring that products are produced and controlled according to rigorous quality standards....
by Dr. Yashashwini Reddy | Nov 28, 2024
Drug Approval Process in India: Simplified Steps Getting a new drug approved in India involves multiple steps to ensure safety, effectiveness, and quality. Here’s a simplified overview: 1. Pre-Clinical Testing Laboratory Testing: Conducted on cells and animals to...
by Dr. Yashashwini Reddy | Nov 28, 2024
Why Data Integrity Matters in Pharmaceuticals: Insights from Patients and Regulators In pharmaceuticals, “data integrity” ensures data remains accurate, consistent, and reliable throughout its lifecycle. It forms the backbone of quality assurance in...
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...
