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Biomedical Engineering; Medical Devices
IP Projects Catheter stabilizing device Dental Instrument Implant Seeds Intrauterine pressure catheter Vascular Catheters (3) Over 30 years experience in medical product design and development experiences in Anesthesiology, Assistive Technology, Cardiovascular, Catheters, Critical Care, Endoscopy, Implants, Instruments, IV Systems, Home…
Quality Assurance Engineering
Expert has over 15 years of experience with quality assurance. He provided Quality Assurance support to insure timely and cost effective: systemic, design, component and product compliance. His activities included supporting: New Product Development, Design Reviews, Verification and Validation, Material…
Medical Device, Diagnostic, and Pharmaceutical Clinical Trial Design and Strategy
Expert has over 25 years experience in commercializing medical products. Her experience includes management at Abbott Labs in clinical research and regulatory affairs and as a CEO of a venture capital backed medical diagnotic company. Expert has raised venture money…
Marketing Plan Development, Market Research, Brand Identity, Market Share Increase
In addition to selling advertising space for a local weekly business publication, Expert has worked for brand development and sales promotion advertising agencies. As a supplier of brand development services (package design, print promotion) to one of the largest consumer…
Biomaterials: Biocompatibility, Pathology, Devices
Expert J. Expert is a D.V.M. with a Ph.D. in veterinary pathology. He is also board certified by the American College of Veterinary Pathologists. As part of his Ph.D. research training he was involved in the characterization of several spontaneous…
Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the…
Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs
Expert is active in U.K. General Practice with wide therapeutic area knowledge and practical patient prescribing. He has a good understanding of the U.K. health system, formulary adoption, N.I.C.E., and reimbursement. Expert has 15 years of experience in the design,…
Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals
Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst,…