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Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Pulmonary Hypertension Drugs, Nitric Oxide and Nitric Oxide Delivery Systems
Seasoned Executive with a unique combination of scientific and business expertise in the pharmaceutical industry. Over 18 years of drug development experience (i.v, subcutaneous, inhaled and oral products), 15+ years in Pulmonary Hypertension, including 10 years in years at a…
Pharmaceutical/Biotech Marketing | Brand Marketing | P&L Management | Commercial Strategy
Expert is a strategic advisor to the life sciences industry drawing on more then 25 years of sales, marketing and managed markets experience in commercial healthcare organizations. He has worked both as client and vendor (pharma/biotech executive and ad agency…
Medical Device Software, Safety Critical Systems, Embedded Systems Design
Expert managed the Electrical Engineering department of a consulting company specializing in medical device design. He has designed software, firmware and hardware for medical devices including a Proton Beam Radiotherapy system, blood infusion pumps, blood analyzers, hysterscopic pump, drug scanning…
Pharmaceuticals, Biotechnology, Clinical Pharmacology, Pharmacokinetics, Clinical Trials
Expert is an expert in drug discovery and development years of experience in clinical pharmacology, pharmacokinetics and clinical trials of pharmaceuticals. Trained in medicinal chemistry, Expert undertook clinical pharmacology research in a University Hospital for 12 years before joining the…
Hypertension, Chronic Kidney Disease (CKD), End Stage Kidney Disease (ESRD), Dialysis
Expert is board certified in internal medicine with a subspecialty in Nephrology. He has over 30 publications in journal and review articles on topics such as hyperfiltration in diabetes, angiotensin, salicylate toxicity, renal vascular disease, dialysis, nephropathy in patients with…
Phytochemistry, Ayurvedic Dosage Forms, Ayurvedic Panchakarma
He is a leading Phytochemist in Mumbai. He has a unique combination of working as Phytochemist, Analyst, Organic Synthesis & Ayurvedic Panchkarma Expert. He has developed more than 25 new and 13 generic formule for Ayurvedic remedies. He has cured…
Drug Discovery & Development Technology and Intellectual Property (Patents, Trade Marks, etc.)
He has had the Drug Discovery Department, as part of his role as Director R & D, at Wockhardt Limited, discover several new NCEs during the tenure of this position, which NCEs are more extensively described in a later section…
Due Diligence, Competitive Differentiation, Science Scouting, Innovation Assessment, Research Tools, Expert Witness, Cancer Biomarkers, Cancer Immunology, Assay Development, Research Devices
Developed multiple novel immunoassays and immunology products for start-up biotechnology company. Founding Director, Research and Development for privately held company in San Diego. Oversaw innovation and entrepreneurship at Mitchell Cancer Institute resulting in 5 spin-out biotechnology companies in the area…