- Reasons for FDA violations….
- EU and US agree to share API and drug plant inspection data…!!!
- Regulatory Definitions for “Ambient”, “Room Temperature” and “Cold Chain”
- Quality by design approach: Regulatory Aspect………..!!!
- Bioavailability and Bioequivalance the Basic Approach…..
- BIOWAIVER….The Way Forward..
- DMF (Drug Master File)
- Drug Regulatory Agencies across the world
- Regulatory Affairs & its Role in Pharmaceutical
- Effective Dossier Management in Regulatory Affairs
June 26, 2017
- Negative Control & Positive Control in Microbiological Sterility Testing.
- SOP on Guideline for Preparation of Site Master File
- Recording System for U.V. Lamp burning hours
- Water for Injection in Pharmaceutical Industry: Introduction and Methods of Production
- Sampling Plan for Water system- From initial to routine
- SOP on Change Control Management
- Now Indian Pharma Companies Need to Get Rid of “Jugaad” and “Chalta-hai” Attitude
- SOP on Market Complaints