Vijay U. Kshirsagar

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TRAC Pharma Consulting
Director & CEO
•Hard core QA , Regulatory & Analytical professional with almost 39 years of rich experience of working for reputed Indian & Multinational Pharmaceutical firms like Unichem, Ranbaxy, Sun Pharma, Lupin, IPCA & German Remedies.
•Till April 2013, worked for Unichem Laboratories Ltd, Mumbai as Executive Vice President responsible for Corporate Quality, Regulatory, Analytical Research & Pkg Development for almost 7 years. I still continue to be associated with Unichem as Technical Advisor.
•Effective 1st May 2013, I have started my own Pharma Consultancy called TRAC offering specialized services for Training, Regulatory, Auditing & Compliance.
•Successfully represented my company in US & UK courts regarding IP related matters (Para IV).
• Led from front for several successful regulatory inspections such as US FDA , MHRA, EDQM , ANVISA, WHO & TGA . These inspections covered both Drug Products & API’s.
• Instrumental in driving the filings of dossiers for various markets like US/EU/Brazil/Australia/SA & ROW including several ANDA’s/ MAA’s/DMF’s/ASMF & CEP applications. I have written QOS for these filings as an Expert.
•I have been a frequent trainer in India & abroad through platforms like ISPE, IDMA, IPA, CPHI, USP, PPS, SPDS etc.
•I have spoken on variety of topics related to cGMP, GLP, CV, AMV, Stability testing, Dissolution testing, Microbiological Validations, OOS, OOT, QbD, PAT, Aseptic Monitoring, Handling Regulatory Queries, Root Cause Analysis, CAPA etc.
• Conferred upon with an ‘Outstanding Analyst Award 2012’ by IDMA (Indian Drug Manufacturers Association) for my contribution towards pharmaceutical analysis. IDMA has published guideline on CAPA written by me.
•I have a Post Graduate degree (M.Sc.) in Organoanalytical Chemistry by Research, from Mumbai University. Microbiology was my principle subject at graduation level.
•I have been a member of ISPE for more than 10 years. I am associated with ISPE, India as Director on the board. I am also the President of Society for Pharmaceutical Dissolution Science (SPDS) & Chairman of Stake holder’s forum for Western India.