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...
by Dr. Yashashwini Reddy | Nov 21, 2024
Parts of Analytical Validation in the Pharmaceutical Industry Analytical validation plays a crucial role in ensuring that pharmaceutical products meet the highest standards of quality, safety, and effectiveness. It confirms that the methods used to analyze these...
by Dr. Yashashwini Reddy | Nov 5, 2024
1. The Indian Patent and Design Act, 1970 Focused on encouraging innovation, this act initially allowed only process patents, enabling Indian companies to produce affordable generic drugs. Over the years, the act evolved, aligning with international standards to...
