Expert manufacturer of high protein low carbohydrate foods and beverages including soy isolate, high energy bars and beverages, fish protein, whey protein, infused fruits and vegetablesManufacture of high protein low carbohydrate bar formulations.Production of high energy and sport beverages; fruit and vegetable juice processing.Facility startup for sugar replacement blends; infused fruits and vegetables, soy isolate, fish protein concentrates, whey protein concentrates.Food product formulation, herbal extraction, food dehydration.Quality Assurance and SOP's for food and dairy products.Food industry membrane processing.

Food and Dietary Supplement Consultant specializing in Open Innovation NPD, Microencapsulation and HydrocolloidsFood product development and technology.Microencapsulation technology and delivery systems.Hydrocolloid technology.Functional foods and dietary supplements.Confectionery and chewing gum, baking, beverages and sweet goods experience.Technical management and open innovation development.Expert witness (defendant and plaintiff).Lab build-out and lab management experience.Flavor technology.Short-course developer and adjunct professor at Montclair State University and Rutgers University.

Regulatory Expert in the Fields of Food and Feed Additive Safety Assessment, GRAS Notifications, Food Additive Petitions, Quality, Hazard Analysis and Good Manufacturing PracticeRegulatory support in the fields of food and feed additive safety assessment, GRAS notifications, food additive petitions, quality, hazard analysis and good manufacturing practice.GRAS Notifications for CFSAN and CVM, and FSMA compliance.Broad knowledge of the fermentation-derived enzyme, food ingredient, food and feed additive, and dairy culture fields.Additive, ingredient or product safety assessment, preparation and submission of GRAS notifications or additive p...

Food Chemical Expert Specializing Chocolate, Fruit Snacks, General Confectionery Products, Cereals, Pet Foods and High Protein Analog Food Products in Domestic and International Food MarketsOperations expert and senior level product development for research and development and quality control.Chocolate, fruit snacks, general confectionery products, cereals, pet foods, and high protein analog food products in the domestic and international food markets.Competitive product analysis focusing on flavor, color, texture, size, count, process, and wrap. Other product areas: Ingredient copy, claims, and nutrition facts.Retail audits: Product pos...

Food Safety Expert In Surveillance, Outbreak Investigation, Prevention and Control Strategies, Risk Management, and Consumer BehaviorHealth hazards of ready-to-eat foods.Standards for poultry processing.Harmonization of food safety regulations.Food safety policy.Significance of temperature for microbial growth in foods.Canned food methodology and post process leakage.Outbreaks of botulism in northern communities.Detection of foodborne pathogens in various foods.Epidemiology of disease and costs caused by seafood toxins (PSP, DSP, domoic acid, ciguatera, tetramine).Dose-response and detection of seafood toxins.Surveillance and economics of...

Food engineering, food processing, food packaging, food Extraction equipment, food extraction methods, natural products isolating, Solvent extraction Engineering, facilities solvent extraction plant concentration, source products, process development, process design, for extraction of oil from aqua-cultured oil extraction, products processing waste, salmon processing waste, flash drying system Design, Edible oils extraction, Edible oils refining, Process engineering, commissioning, evaluation trials, fishmeal drying process upgrades, technical feasibility studies, Plant layouts, plant upgrades, PFD- Process Flow Diagram development, heat balance calculations, mass balance calculations, antioxidant concentrate extractions, blueberry and cranberry pomace, Capital cost estimates, equipment sourcing, Soybean expeller, biodiesel manufacturing, Equipment layouts ,piping layouts, fish gelatin manufacturing, plant expansion, existing systems improvements, Refining, hydrogenation, deodorizing, esterification, jojoba votating, macadamia nut oil votating, cosmetic Ingredients, oil extraction, enzyme hydrolysis, aquaculture salmon processing waste, CIDA, Canadian International Development Agency), : drying System design, potato starch plant dryers, seal oils, marine edible oil refining, fatty acid concentrate, medicinal products, Production line design, canned goods, retorted pet foods, spinflash drying system, clam depuration, freshwater fishmeal plant, HACCP (Hazard Analysis Critical Control Point), pharmaceutical end products, ASEAN, region (Association of Southeast Asian Nations), low temperature rendering, alkali refining, steam refining, bleaching, hydrogenation, deodorization, interesterification, margarine/shortening solidification, packaging, propylene glycol ester manufacturing propylene glycol ester emulsifiers. Natural Extraction, Agricultural, fishery by-products processes,

Ph.D. Legal Consultant, Providing Various Expert Support in: FDA Approvals, Evaluations-Patents Medical Devices and Drugs, Data Integrity and Software Development, Author and Expert Report Writings.  Regulatory, Food and Drug Administration (FDA)-related provisions and cases providing support to legal clients in areas: Death or injury caused by drugs, biologics or medical devices, (patents, insurance claims, wrongful termination, trade secrets, merger and acquisitions. Develop and present more than 40 FDA related technical, regulatory and compliance topics to over 50,000 participants. Depositions. Develop case-specific informat...

Pharmaceutical Regulatory Affairs Consulting in: Project Management, Quality and Compliance - NDA, ANDA, DMF and eCTD - Domestic and InternationalHigh-performing Regulatory Affairs and Compliance Professional with over 25 years of diverse pharmaceutical experience in sterile injectable, solid dosage, oral solution, and inhalation product environments. Demonstrated knowledge of regulations and the NDA/ANDA/DMF eCTD submission process with a successful track record in obtaining over 200 drug product approvals. Proven expertise in negotiating effectively with the U.S. FDA applying broad understanding and experience in handling p...

Interpretation and Analysis of Technical Intellectual Property Related Documents in English and Japanese. Biochemistry and Cellular Biology Background in Biologics and Small Molecule Drug Discovery and Development. Drug Substance In Vitro Assay Development and StandardizationInterpretation and analysis of highly technical Japanese documents in English.Pharmaceutical and biotechnology research project management.Biochemistry - cellular biology background: Biologics and small molecule drug discovery and development.Liaison and interpreter for licensing and material transfers to and from Japanese organization.Manager of in vitro pharmacol...

Ph.D. Food Science Consultant with Expertise in Food Products, Food Poisoning, and Food Regulatory IssuesFood Science and TechnologyFood SafetyFood PoisoningNatural Ingredient ClaimsFermentationAntimicrobialsProbioticsBotulismAnthraxSporesSpoilageListeria monocytogenesExpert Witness ExperienceConsultant and Expert Witness, various major food companies and law firmsNatural Ingredient Claims - furnished opinions in eight cases as defendant's expert for major food companies affirming that food ingredients such as citric acid, high fructose corn syrup, gelatin, xanthan gum, etc. are natural.Intellectual Property - provided opinion and testifie...