Mr. Vijay Kshirsagar is a distinguished Quality, Regulatory, and Analytical professional with an extensive career spanning over 38 years. He has made significant contributions to the pharmaceutical industry, working with prominent Indian and multinational pharmaceutical firms, and serving as a consultant for the past decade.

Professional Experience

Vijay’s most recent role was as the Executive Vice President at Unichem Laboratories in Mumbai, where he was responsible for Corporate Quality Assurance (CQA), Regulatory Affairs, and Analytical Research. After 11 years, he transitioned to an advisory role on quality and regulatory matters. His previous roles include senior positions at renowned companies such as Ranbaxy, Sun Pharma, Tata-Merind, IPCA, German Remedies, Lupin, and Duphar Interfran, where he held titles like Director of Quality and General Manager of Quality.

A proven leader, Vijay has successfully guided teams through numerous regulatory inspections by global agencies such as the US FDA, MHRA, EDQM, and WHO, among others. He has a notable achievement of converting a Cephalosporin facility to a general product facility, earning MHRA approval, a first in India.

Contributions and Recognition

Vijay is the founder and President of the Society for Pharmaceutical Dissolution Science (SPDS), a global platform where he was honored with the “Leadership Award.” His contributions to pharmaceutical analysis were also recognized with the “Outstanding Analyst Award 2011” by the Indian Drug Manufacturers’ Association (IDMA). Additionally, he served on the board of directors for ISPE-India for 12 years.

As a thought leader, Vijay has published articles in esteemed journals and contributed a chapter on ‘Out-of-Specification (OOS) Investigations’ for pharmacy students. His guideline on Corrective and Preventive Actions (CAPA) is published by IDMA.

Education and Mentorship

Vijay holds a Master of Science by Research in Organoanalytical Chemistry from Mumbai University and has a strong foundation in microbiology. He is also a mentor to prestigious pharmacy colleges in Mumbai.

Consultancy and Global Impact

In 2013, Vijay founded TRAC, his own pharmaceutical consultancy that offers specialized services in cGMP training, regulatory filings, auditing, and compliance. His consultancy has a diverse clientele across India, China, the US, Europe, Turkey, Bangladesh, and Malaysia. Vijay has been instrumental in aiding companies to secure and sustain international regulatory approvals, as well as assisting in remediation plans to restore regulatory compliance.

Mr. Vijay Kshirsagar’s career reflects a profound commitment to excellence and innovation in the pharmaceutical sector, making him a respected figure and sought-after consultant worldwide.