Vijay Kshirsagar is an accomplished Quality, Regulatory & Analytical professional with about 40 years of rich experience of working for highly reputed Indian & Multinational Pharmaceutical firms. Till end April 2013, he worked for Unichem for about 7 years as Executive Vice President responsible for Corporate Quality, Regulatory, Analytical Research, Bioanalytical services & Pkg Development based in Mumbai. Thereafter he continues to be associated with Unichem as Advisor on Quality & Regulatory matters. Prior to Unichem he worked for Ranbaxy, Sun Pharma , Lupin, IPCA, German Remedies & Tata Pharma in various capacities including senior positions like Director-Quality , GM-Quality etc . He has successfully represented his company in US and UK courts regarding IP related matters (Para IV filings).

Vijay has led from front for successful completion of several regulatory inspections by US FDA, MHRA, EDQM, ANVISA, WHO, TGA etc. both for Drug Products & API’s. He has been instrumental in driving the filings of dossiers & DMF’s for various regulated & semi-regulated markets. He has been a frequent trainer in India & abroad having spoken on wide range of topics including cGMP/GLP/PQS/ Validations/Regulatory Aspects/ QbD/Investigations/ Auditing & Validations. He is currently working on the board of Directors of ISPE-India. He is also the President of ‘Society for Pharmaceutical Dissolution Science’. IDMA has conferred upon him an ‘Outstanding Analyst Award 2011’ for his contribution towards pharmaceutical analysis. Guideline written by him on CAPA is published by IDMA. He has also published articles on cGMP related topics like OOS, QbD & cGMP in reputed journals/books. His chapter on ‘OOS Investigations’ is a reference material being a part of the book for Pharmacy students. In 2015, he has been specially awarded by Unites States Pharmacopeia, India for his contribution to USP’s Stakeholders Forum. He is M.Sc. by Research in Organoanalytical Chemistry from Mumbai University. He has a good Microbiological background too having done his graduation with Microbiology as a principle subject.