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Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics
PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and Employer. A proven track…
Medical Devices, In Vitro Diagnostics Design, Quality Control, Trouble-Shooting, etc.
Expert has authored and submitted 510(Experts for more than 25 IVD (In Vitro Diagnostics) products. These 510(Experts encompass a variety of IVD products from manual, semi-automated to fully automated non-isotopic diagnostic tests including point-of-care devices. Expert has the expertise to…
Assay Development/Molecular Biology
The expert's private consulting and research company was established to provide innovative solutions to technical problems for researchers in academia and industry. Its charter is to develop strategies and protocols that streamline scientific research in the most time/cost effective ways.…
Clinical Chemistry, Laboratory Diagnostics, Immunoassay Development, Therapeutic Drug Monitoring
Expert has extensive experience in the field of clinical chemistry and clinical diagnostics. Development of analytical methods for trace analytes in biological fluids, especially in the field of clinical diagnostics, has been Expert's main job responsibility and success over the…
Biotechnology: All Areas of Business and Technology
Expert has extensive hands-on experience with, and knowledge of, deoxyribonucleic acid (DNA) probe technology, having worked in this area for 10 years. He used nucleic acid probe technology to characterize mammalian viruses and oncogenes while performing research supported by the…
Fluorescence Spectroscopy, Analysis of Metal Ions by Chelation with Organic Ligands, etc.
FLUORESCENCE SPECTROSCOPY. Expert has worked in the area of fluorescence spectroscopy for almost thirty years. He has published extensively on the influences of pH and solvent composition upon fluorescence spectra and has used these phenomena to study the rates and…
Automotive and Small Engines
Expert has built or rebuilt over 30 automotive (chassis dyno) or engine test cells, most with sophisticated automated data acquisition and control systems. He is currently operating both automotive chassis dynamometer and small engine dynamometer tests at a state-of-the-art emissions…