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...
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 24, 2024
Career Opportunities in Project Management for the Pharmaceutical Industry The pharmaceutical industry offers exciting career prospects for individuals interested in project management. As the industry continues to grow and innovate, skilled project managers are in...
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...
