Pankaj Kumar

WORK HISTORY

EDUCATION

ABOUT PANKAJ KUMAR

I am a U.S. CLIA Board-Certified High-Complexity Laboratory Director (HCLD) and senior laboratory advisor specializing in clinical diagnostics, regulatory governance and cross-border laboratory infrastructure.I provide executive-level leadership for laboratories operating under CLIA, CAP, and international accreditation frameworks, supporting assay commercialization, compliance governance, and scalable laboratory operations.My work includes governance of high-complexity testing, validation and launch of LDT and IVD assays, and clinical sign-out across diagnostic immunology, neurology, molecular diagnostics, oncology biomarkers, and advanced chemistry.I also advise Canadian and international laboratories entering the U.S. market, guiding CLIA certification, regulatory compliance, validation strategy, and clinical reporting governance, including FDA-regulated and U.S-bound clinical trials.I focus on building inspection-ready, scalable laboratory infrastructure that protects regulatory standing while enabling sustainable growth.If you are preparing for CLIA entry, laboratory expansion, or clinical commercialization, I welcome the opportunity to connect.