Director & CEO, TRAC Pharma Consulting
Mr. Vijay is an accomplished Quality, Regulatory & Analytical professional with about 40 years of rich experience of working for highly reputed Indian & Multinational Pharma firms like Unichem, Ranbaxy, Sun Pharma , Lupin, IPCA, German Remedies in Sr positions like EVP, Director & GM- Quality & Regulatory. He has led from front for several successful regulatory inspections including US FDA, MHRA, WHO, EDQM, ANVISA, TGA both for Drug Products & API’s.
Since 2013, he is running his own Pharma Consultancy called TRAC offering specialized services globally, for cGMP Training, Regulatory Filings, Auditing & Compliance. His current clients include reputed pharma companies based in India, China, Bangladesh, Turkey, US, Europe, Malaysia etc.. He is a frequent international trainer on several cGMP related topics.
He is the founder President of ‘Society for Pharmaceutical Dissolution Science’. He is currently working on the board of Directors of ISPE-India. IDMA has conferred upon him an ‘Outstanding Analyst Award 2011’ for his contribution towards pharmaceutical analysis. He has also published articles on cGMP related topics like CAPA, OOS, QbD & cGMP in reputed journals/books. He is M.Sc. by Research in Organoanalytical Chemistry from Mumbai University. He has a good Microbiological background too.
Email: vukshirsagar@tracpharmaconsulting.com
Management Executive Council
