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Pharmacovigilance
Pharmacovigilance professional with 18 years’ experience developing and reengineering PV departments in small to medium sized pharmaceutical/biotechnology companies. Operational expertise includes the evaluation, development and implementation of PV processes and infrastructure, vendor management, SOP development and revision, CAPA management, compliance…
Food Safety, Nutrition, Regulatory Matters, Health and Wellness, and Business Strategy
With experience in the public and private sectors, Expert provides advice and guidance on a wide range of topics. She has senior experience in health and wellness, business strategy, product development, regulatory compliance, food safety, quality systems management, supply chain,…
Medical Devices, Business Development, Regulatory Affairs, Project Management
Expert successfully launched over 25 new instrument and disposable medical devices. He developed and managed numerous cross-functional and cross-cultural new product and process teams. He has developed rich experience in team leadership and assembly, grounded in RA/QA fundamentals (RAC Certified).…
Hepatology Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) Liver Disease, Pharmacovigilance, Drug Development- Drug-Induced Liver Injury Hepatotoxicity
Expert has been a hepatologist since 1988. She was in a solo practice devoted to treating and evaluating patients with liver disease until 2009 at which time she became Director of Hepatology. During that time she served as a consultant…
Marketing Strategy and Marketing Research
Expert has over 30 years of experience in marketing research and marketing strategy. At major companies such as Procter & Gamble, Kraft Foods and Dunkin’ Donuts, she worked across disciplines, including marketing research, branding/positioning, new product/concept development, brand management, marketing…
BioPharmaceutical Commercialization
New product planning, business development, and marketing professional with transactional, launch, and expert witness experience. Expertise in new product commercialization, licensing, valuations, deal structure, strategic brand planning, long range forecasting, pricing & reimbursement, HEOR strategies, payor communications, tactical program implementation,…
Pharmaceutical Processing and Packaging
Expert has over 20 years of experience in engineering and technical services. He has lead teams of engineers working in development, material qualification process development/ qualification, as well as lifecycle management for both new and existing combination/ non-combination products. Expert…
Toxicologist, Dietary Supplement and Functional Food compliance
Experienced toxicologist with knowledge of product formulations, regulatory requirements, and analytical evaluation of test results. Worked as a toxicologist for NSF International for 15 years in dietary supplements and functional foods. Have been self-driven and working from home for the…
Machine Learning, Computer Vision, Natural Language Processing, and AI
Expert founded three technology companies and co-led them to successful acquisitions, including one to a leading manufacturer in the Apple supply chain. He has been featured by Bloomberg Business Week as one of America's Best Entrepreneurs. His work has been…
Mechanical Engineering, Warning Labels, Human Factors
Expert is an Emeritus Professor at the University of Michigan and a registered professional engineer and consultant with over 35 years of experience as an expert witness. He specializes in warnings, labeling, and instruction manuals, consumer product design, process safety,…