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Fermentation, Scientific and Regulatory Affairs
Expert is dedicated to commercializing novel ingredients for health and sustainability Proficient in human pathology, plant biology, synthetic biology, and fermentation technology. Her specialties include Product Innovation and Formulation, CPG Application Testing COGS and Process Improvement, Food Science, Safety and…
Ingredients, Nutraceuticals, IP, Regulatory Procedures, Expert Witness, Competitive Intelligence
A diversified scientist, with a demonstrated ability to conceptualize and manage ideas leading to technology patents, new product categories and new business opportunities for corporations, associations and start-ups. She is currently retained by entrepreneurial and corporate sectors to help create…
Medical Device Failure Analysis, Medical Device Product Liability, Patent Infringement Analysis, Patent Invalidity and Validity Analysis, Patent Claim Construction
Expert has over 20 years in the medical device and electronics industries, with contributions exemplified in the numerous products that were developed under his leadership. These products today are improving the quality of healthcare, in hospitals, sub-acute and alternate care…
Pharmaceutical Formulation (Tablets, Capsules, Semi-solids, Liquids), QbD, and CMC Regulatory/Risk Assessment Issues
Expert is a Pharmaceutical Formulation Scientist with 25+ years' industry/FDA experience developing and commercializing tablets (fast dissolving, effervescent, chewable, coated), capsules, ODT's, coated beads (i.e., controlled release and taste-masked), topicals (liquids and semi-solids), & CBD/hemp products. He also has experience…
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…
Agronomy, Regulated (GMO) & Regulated Crop/Seed Production, Management, USA, International shipments
Expert's experience in agricultural development includes introduction of center pivot irrigation for irrigated corn to western Nebraska in the early 1970's when the area had previously been considered only as a dry land wheat production land. He also worked in…
Software Development, Technical Writing, and Project Management
Expert has experience with Software development tools for embedded systems engineers, marketing, project management, and technical publishing. The technical publications Expert develops show three essential qualities: close attention to the needs of the audience, correct content, and a clean look…
Biomedical Device Engineering
BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product…
Food Microbiology, Toxicology, Preservation, and Spoilage; Yeasts; Clostridia; Botulinum Toxin
Expert's primary area of research is the study of botulinum toxin in the gram-positive pathogen Clostridium botulinum. Much of his work has been devoted to methods for the prevention of toxin formation in foods. He has also contributed to the…