Experienced pharmaceutical laboratory manager and analytical chemist with expertise in GLP and GMP compliance and solid dosage forms.Extensive experience in pharmaceutical, nutraceutical and chemical industry analytical laboratories.Laboratory management and analytical laboratory improvement, cGMP and GLP compliance and problem resolution.Pharmaceutical process, cleaning and analytical methods validation.Solid dosage for OTC drug products.Responsibility for QA/QC functions for testing, complaint handling, customer audits and data analysis for over 300 different drug products.Training on cGMP and GLP compliance and problem resolution.Docume...

Competitive analysis, benchmarking, market and industry analysis, due diligence and management counsel. Numerous business research studies for companies interested in companies, products, channels of distribution, and industry trends and forecasts.Technical marketing research: Demand, supply, pricing, competitive assessment product attribute measurement and valuation.Competitive analysis, benchmarking, market and industry analysis, due diligence and management counsel.Conducted many market/business research studies for companies interested in acquisitions, new product development, product pricing, channels of distribution and industry tr...

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.

Expert for Pharmaceutical Equipment Sales and DistributionFormulation process development of pharmaceuticals and nutraceutical dosage form.Tablets, capsules, injectables, creams, ointments and controlled release products.Regulatory requirements for pharmaceutical and nutraceutical including FDA, DMF, NDA, ANDA, cGMP, SOPs, auditing, labeling.Process controls including validations, operations, specifications, equipment selection, and qualifications, IQ/OQ/PQ.International liaisons/licensing of pharmaceutical and nutraceutical raw materials, finished products.Sales and marketing including setting up broker, distributor, retailer network, new...

Canadian License Applications for Natural Health Products, Cosmetics and PharmaceuticalsPerforming key pre approval and post approval activities for drugs intended for the Canadian marketplace.Preparation of DIN applications for submission to Health Canada.Product license and site license applications and amendments for natural health care products.Drug establishment licenses for Canadian importers, packagers and distributors.Responses to Health Canada deficiency notices.Expert WitnessRelated to Notice of Compliance (NOC) issues.Independent Consultant,...

Chemical Synthesis Consultant of Natural Products for Medicinal ApplicationsSynthesis of natural products for medicinal applications.Understanding and cataloging of non-prescription drugs.Synthesis of aristolochic acid and derivatives.Synthesis of substituted indole-3-caboxamide compounds as local anesthetics.Photochemical synthesis of phenanthrenes.Synthesis of biotin analogs for biochemical enzymatic studies.Synthesis of anthracycline derivatives as anticancer drugs.Synthesis of novel heterocyclic ring systems as potential drugs.Education in medicinal chemistry and pharmacology.Poison ivy and poison oak remedies.

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.

Brewmaster Specializing in Solving Brewing Process Problems, Commissioning New Brewing Equipment, and Improving the Financial Performance of Brewing OperationsExtensive experience in all aspects of the brewing process and skilled at locating the source of beer quality issues and resolving these issues.Troubleshooting sources of microbiological contamination and identifying process improvements to eliminate the contamination.Yeast health and fermentation diagnosis, resolving issues and identify process changes to improve yeast vitality and subsequent fermentation vigor.An expert beer taster who can identify beer off notes and identify proce...

Board Certified Toxicologist: Pharmaceutical, Nutraceutical and Consumer Healthcare ProductsFocused toxicity investigations in the consumer health, nutrition pharmaceutical and product safety industries.Drug and food ingredient preclinical development, (all phases) and healthcare products (OTC and personal care products).Product safety and product regulatory consultant frequently interacting with FDA, EPA, international regulatory agencies, U.S. and foreign pharmaceutical and chemical companies.Risk assessments and management of preclinical development and regulatory programs for pharmaceutical, nutraceutical, consumer healthcare, and ch...

5 - Meta Description Formulation Development and Manufacturing Technology Expert of Pharmaceuticals, Nutraceuticals and Cosmetics Multiple Delivery Platforms. Extensive Experience Working with FDA, DEA (U.S.A.) EMEA, EFSA (Europe), TGA (Australia), NHPD, and HPFBI(Canada).Formulation development and manufacturing technology of pharmaceuticals, nutraceuticals and cosmetics on any delivery platform.Analytical oriented work in solids, liquids, topical and sterile products, over the counter - OTC, non-prescription medicines, vitamins, and nutritional products.Development and manufacturing management with focus on dietary supplements, respira...