by Naveen kumar | Nov 27, 2024
1. What is Developmental Quality Assurance (DQA)? A: Developmental Quality Assurance ensures that quality is built into a product during its development stages. It involves reviewing documents, processes, and protocols to meet regulatory and quality standards...
by Naveen kumar | Nov 27, 2024
Interview Questions and Answers on Module 3.2.P (Drug Product) Under Quality – CTD 1. What is the 3.2.P section of the CTD? Answer: The 3.2.P section in Module 3 of the CTD deals with the drug product. It provides detailed information about the finished dosage...
by Naveen kumar | 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 Naveen kumar | 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 Naveen kumar | 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...
