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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…
Healthcare Consulting: Strategic Planning, Product Development, and Product Launch
Expert has been providing expert strategic and operational advisory services to healthcare investors and development stage healthcare companies for nearly 10 years. He has been involved in direct healthcare management for over 15 years, and has been practicing medicine since…
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…
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,…
Engineering Management
Expert has been involved with the re-engineering of new product development processes, creation of total quality management programs, and organizational structure changes for process engineering and research and development functions for two major medical device manufacturers (i.e. Johnson & Johnson…
Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in bringing products…
Integrated Business/Technology Planning, Strategic Planning, Small/Medium Business Analysis
Expert has a deep understanding of virtually all aspects of business development, including customer needs; operations efficiency and effectiveness. He has provided advice and counsel for numerous small businesses and has managed in-depth studies of telecommunications and information handling requirements…
Automated Chemical Sensors
LABORATORY COMPUTERIZED ANALYTICAL INSTRUMENTATION DESIGN; CHEMICAL AUTOANALYSIS. Expert has spent much of his career developing systems or subsystems for devices accomplishing automated chemical analysis. He has experience in all phases of this process, from basic research into sensors to the…
Medical Device Total Quality
FDA REGULATION. A significant portion of Expert's career has been devoted to FDA approval and regulation of medical devices, particularily those with significant risk. He is the President of a consulting company specializing in process validation, FDA/regulatory consulting, and auditing.…