by Dr. Yashashwini Reddy | Apr 22, 2025
Standard Operating Procedure (SOP) Here’s a detailed Standard Operating Procedure (SOP) for Preparation of Working Standards used in analytical laboratories: 1. Purpose To describe a standardized procedure for...
by Dr. Yashashwini Reddy | 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 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
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...
