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Product Development, Product Safety, Regulatory Compliance, Claims Support, Litigation Support
This expert has training and experience in the following areas: Safety of foods, cosmetics and their ingredients; and medical devices, pharmaceutical actives and excipients. Regulatory affairs related to foods, cosmetics, and medical devices. Product development of foods and cosmetics. Management…
Biotechnology, Enzymes, Environmental Bioremediation, Regulatory Compliance
Expert has over 40 years of experience in both basic and applied Biochemistry (biochemical research and enzymology) and Biotechnology. He is very successful in finding flaws in published and spoken materials. His strengths are in the fields of physical biochemistry,…
Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…
HACCP, LACF, Low Acid Aseptic, Process Controls, Process Improvement, System Design, Value Added, Resource Allocation
Expert is a consultant to the Food Manufacturing and Process Industry utilizing excellent interpersonal skills and an aggressive hands on approach. He has successfully liaised with clients and staff, identifying and correcting for food and ingredient manufacturing issues proactively as…
Food Chemistry, Sensory Evaluation, Food Microbiology, Laboratories Accreditation, Quality Systems
Expert has several years of professional experience in Food Analysis, Food Chemistry, Food Microbiology, Quality Assurance of Food Microbiological and Chemical Laboratories, Quality Assurance of Mycotoxins Analysis Laboratories, Quality Assurance of Sensory Analysis Laboratories, including extensive work in application of…
Food Technology, Nutraceuticals, Natural Health Products, Quality Systems
Expert has extensive knowledge and experience in the food science area, with specific focus on food ingredients. With over 20 years experience in food product development, with emphasis on ingredient processing, he has specific expertise in the development of powder…
SARS-CoV-2 Coronavirus, COVID-19, Sanitization Procedures, Forensic Science, Toxicology, DNA Analysis, Food Poisoning, and Toxic Torts
Expert is a Full Professor of Toxicology and has received grants from NIH in the area of Applied Toxicology. Expert has received grants from NIH in the area of Biotoxicology. Part of his research entails molecular analysis of toxins. Expert…
Brewing
Expert worked in brewing research and quality control for over thirty-one years with Miller Brewing Company. He was a principal research microbiologist for many years with expertise in fermentation, yeast handling, yeast genetics (including genetic engineering and gene expression), food…
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…