Almost Nine years of experience in the field of Clinical Research as a Quality Assurance Lead Auditor (Clinical and Bio-Analytical).
Audited 1000+ projects, 10+ CROs and several in-house inspections during the career tenure.
Successfully completed two international site setup projects (details will be available on request).
Trained on 21 CFR Part 11, ICH-GCP, COFEPRIS, GLP, GMP and NABL Guidelines from several certified agencies.
Sound knowledge on ANVISA, ICH GCP, OECD, USFDA, COFEPRIS, ISO, MHRA, WHO, NABL and other regulatory guidelines.
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