Mr. Vijay Kshirsagar, a seasoned professional with extensive knowledge in pharma and API. Excels in quality, regulatory, and analytical roles. He has skillfully represented the company in IP-related cases in US and UK courts.
Worked for reputed Pharma companies based in India, US, EU, China, Turkey, Bangladesh, Malaysia, Jordan, Oman, Indonesia etc.
Did more than 100 cGMP audits for various pharma/API companies in India & outside.
Experience

45+ years

Regulatory Inspections

Regulatory bodies in pharmaceuticals

A man in a black suit loosening his tie
A man in a black suit loosening his tie
assorted medication tables and capsules
assorted medication tables and capsules
file cabinet
file cabinet
Filing Expertise

Global pharmaceutical regulatory documents

Did specialised cross contamination study for Penicillins/ Cephalosporins
Conducted several training programmes & workshops on topics related to cGMP, GLP, Data Integrity, Regulatory Query Handling, Validations, Failure Investigations, QbD, Dissolution, Documentation etc.
Successfully handled Remediation projects to come out of regulatory issues (USFDA/MHRA)

Photo Gallery

Projects

Successfully led various projects in the pharmaceutical industry, ensuring quality, regulatory compliance, and analytical excellence.

Quality Assurance
man sitting on sofa while using laptop
man sitting on sofa while using laptop
black smartphone near person
black smartphone near person
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person standing near the stairs
woman holding white mug while standing
woman holding white mug while standing
Regulatory Compliance

Extensive experience in regulatory compliance and successful representation in IP-related matters.

Analytical Excellence

Expertise in driving the filing of dossiers for different markets, including ANDAs, MAAs, DMFs, ASMF & CEPs.