Vijay Kshirsagar
Vijay is an accomplished Quality, Regulatory & Analytical professional with more than 38 years of rich experience of working for reputed Indian, MNC Pharma firms & as a Consultant for about 10 years. His last stint was with Unichem as Executive Vice President responsible for CQA, Regulatory & Analytical Research, based in Mumbai, where he continued to be as Advisor on Quality & Regulatory matters for 11 years.
Prior to Unichem, he worked for Ranbaxy, Sun, Tata-Merind, IPCA, German Remedies, Lupin & Duphar Interfran in various 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 the front for the successful completion of several regulatory inspections by the US FDA, MHRA, EDQM, ANVISA, WHO, PICS, PMDA, Health Canada, TGA etc. both for Drug Products (Non-Sterile & Sterile) & API’s. He has been a frequent trainer in India & abroad having spoken on a wide range of topics including cGMP/ GLP/ PQS/QRM/Validations (Process, AMV, Cleaning, Microbiological) /QbD/ Dissolution/ Stability/ Handling Regulatory Queries/ Investigations/ CAPA/ Auditing/ Documentation/EM etc. He has spoken in number of national and international forums including SPDS/ISPE/CPHI/USP/IDMA/HRDF etc. He has a unique achievement of converting the existing Cephalosporin facility to a general product facility & getting it approved by MHRA (first time in India).
He is the founder President of ‘Society for Pharmaceutical Dissolution Science’ (SPDS) which is now a global platform. He was conferred upon “Leadership Award” by SPDS. He has also worked on the board of Directors of ISPE-India for 12 years. IDMA has conferred upon him an ‘Outstanding Analyst Award 2011’ for his contribution towards pharmaceutical analysis.
He has published articles on 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. Guideline written by him on CAPA is published by IDMA. 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. He is a Mentor to two reputed pharmacy colleges in Mumbai.
Post 2013, he has formed his own Pharma Consultancy called TRAC offering specialized services globally, for cGMP Training, Regulatory Filings, Auditing & Compliance. His current clients include reputed Pharma/API companies based in India, China, US, Europe, Turkey, Bangladesh, Malaysia etc. As a consultant, he has helped number of companies to get their first time international regulatory approvals & also sustain them over a long period. He has successfully helped the companies for their remediation plans to revive their regulatory approvals (Post WL/Import Ban).
Contact Details:
vukshirsagar@gmail.com | Mobile: +91 9867650160 | Land Line +91 22 35631827