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Clinical Diagnostics, Life Sciences and Medical Devices
Expert has over 30 years of experience in clinical diagnostics, life sciences, and medical devices. Expert is the President of a health care consultancy. He has experience in the identification, acquisition, and commercialization of new businesses and products in the…
Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Hospital Tests and Kits, Clinical Chemistry, Coagulation, Serum Controls, Manufacturing Processes
Expert received his PhD in Biochemistry (Enzyme kinetics on NAD kinase in 1981), where he proposed a mechanism, Rapid Equilibrium Random with two dead end complexes for the enzyme, using enzyme inhibition studies. He was able to apply this knowledge…
Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet QSR including Design History,…
Life Science, Biotech, Pharmaceuticals: Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization
Expert has over 20 years of experience in strategic innovation, system building, and delivering value solutions for global markets. His focus is on building infrastructure synergies between science, technology, and finance. As a Strategic Advisor, he has experience with: •…
Design & Development of Molecular IVD Assays, including Design Control, Risk Analysis, Submissions
Expert has 15 years’ work experience in the development of nucleic acid -based in vitro diagnostic (IVD) devices. He has both theoretical knowledge and hands-on experience, spanning the entire IVD pathway, which includes biomarker discovery, preclinical & clinical assay validation,…
Strategic Marketing and Business Management in all Healthcare and Medical Sectors
• Successful, enthusiastic, highly motivated, strategic medical/healthcare consultant • Qualified, experienced international business manager & strategic medical marketer • Excellent track record of turning round and growing companies, products & services • Wide span of management expertise across pharmaceutical, medical…
Product Development and Manufacturing Technology Transfer in Composite Materials for Industrial, Biotech and Medical Devices
Expert's principal expertise lies in conducting original research, development, and evaluation of alternative process capabilities, in support of new product development. His work has typically led to the establishment of new manufacturing platforms for a variety of material science-oriented businesses…
Strategy and Sales Analysis for In Vitro Diagnostics and Biopharmaceuticals
Expert has multiple experiences in evaluating and proposing strategy for brands or individual products. This list includes several existing diagnostic products where lifecycle planning needs require judicious selection of new and novel add-ons to an existing line. It also includes…
Microbiology Biotechnology, In Vitro Diagnostics, Public Health, Tuberculosis, Mycology, Archaea
Expert is adjunct Assistant Professor of Molecular Genetics and Microbiology for the University of New Mexico Health Sciences Center and a consultant to several medical and biotechnology companies. Prior to this Expert was the manager of a public health and…