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
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
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.