Experienced Professional

Expert

45+ years of experience

Successful Regulatory Inspections

Court representation in US/UK

Successful IP Related Matters

Market dossier filings summary

Mr. Vijay Kshirsagar is a highly experienced Quality/Regulatory & Analytical Pharma professional, with >45 years of experience. He has led his company/clients for several successful regulatory inspections and has also driven filings (ANDA/MA/DMF/CEP etc). Auditing & Training have been his core activities. He has successfully represented his company in US/UK courts regarding Para IV filings.

Training Programs & Workshops

Happy Clients

*Services provided for these companies were for one or more of activities like auditing/ Training/ Remediation/ Compliance Services etc..

Founder President (SPDS.in)

Professional Associations

Former Director for 12 years

Mentor to Pharmacy colleges

Former Chairman of USP’s Regional Stakeholders Forum

Key Member

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woman wearing blue coat

Trac Pharma Consulting's expertise and guidance have been invaluable in navigating complex regulations

Customer Testimonials

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person holding pencil near laptop computer

Trac Pharma Consulting offered valuable regulatory advice and support, making our experience excellent

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black smartphone near person

We are pleased with Trac Pharma Consulting's services as they helped us comply with regulations and improve processes

Contact Us

Email

Phone

vukshirsagar@tracpharmaconsulting.com

+91 98676 50160
+91 22 35631827