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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…
Adhesive Consulting, Formulating, & Research in Structural, PSA, Hot Melt, Epoxy, Urethane, & Wood
Expert D. Expert has done adhesive failure analysis projects in connection with establishing cause in litigation cases or in research and production problems. For example, a wood millwork manufacturer claimed an adhesive was faulty, resulting in customer loss and damages.…
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,…
Projects & Technologies for the Power & Process Industries
Expert has long association and experience with marketing and commercialization of new chemical process technologies, management, and engineering design and construction. He has provided expert services in approximately 20 legal and industrial insurance cases. Expert earned his bachelor of science…
Clinical Applications, Microbiology, Biotechnology, Diagnostics, Immunology, and Custom Speaking
Expert has been involved in the identification of biological molecules associated with disease and infection with bacterial and viral agents. By applying molecular techniques to vaccine and infection models, he has identified immunological (antigenic) markers of bacterial infections of human…
Proposals, RFP analysis, training videos, books and documentation, MVC C Sharp
Expert is a certified Project Management Professional (PMP). He has been a Sr. Program Manager or CTO for several Fortune 500 companies supporting multi-million dollar programs for several agencies within the Intelligence Community and the Department of Defense. He has…
Facilitating Business Growth Through Commercialization of New Medical and Biotechnology Products
Expert has extensive experience supporting clients in pharmaceutical, medical and industrial markets. An electrical engineer by training, and the principal of his own consultancy for more than 12 years, he brings strong market, business development and technical skills to his…
Competitive Intelligence, Doing Business in Japan, B2B Market Research, Strategic Market Planning
Through Expert's consulting activities, he has assisted clients in developing strategies for new business, product and market opportunities. The basis of these efforts has been to conduct market research on a topic and develop a fact base driven against selected…
Strategic Planning, Marketing, Sales, and Business Development
Expert has a proven track record in leading technology companies as president and in C-level executive positions. He holds an MBA and is certified by the Small Business Administration. His experience includes raising private financing, negotiating and setting up strategic…