Former FDA Investigator - Expert in Regulations, Interpretations, Medical Devices, and Dietary Supplements.Former FDA Investigator.Technical writing to build and implement quality systems.Comprehensive audit and gap analysis.CAPA and FDA responses and complaints including: Investigations, resolution, root cause analysis, corrective action plans, preventative action plans and CAPA effectiveness resolution and documentation.Employee training; laboratory and quality.Formal FDA Training in multiple program areas: Drugs; medical devices; process validation; industrial sterilization; biologics; dietary supplements; food and feed.Ability to audit...

Ph.D. analytical chemist with expertise in Nutraceuticals, Food and Beverage, Regulatory Compliance Packaging, Microscopy and Chemical Imaging, and Reverse EngineeringTrace and Quantitative analysis: Instrumentation, polymer laminates, training, material science, spectroscopy, microscopy, biotechnology, medical industries, providing over twenty years of successfully execution.Water, beverage, food, packaging, environmental, biological and surface chemistry, qualification and analysis with focus in analytical techniques and intuitive improvements.Trace, microbiological and materials analysis for product development, quality control, proces...

FDA Regulatory Affairs and Labeling Expert for Food, Cosmetics, OTC Drugs, Pet foods, and Medical DevicesFood and Drug Administration Regulations (FDA), in foods, dietary supplements, cosmetics, OTC drugs, pet foods and medical devices.Knowledge of allowable marketing claims for FDA regulated consumer products.Research and consumer health product development.Nutrition evaluation of food products.Product formulation and marketing.Undisclosed Company, Owner and Principal, 2001 - PresentProviding clients with over 20 years' experience in b...

Dietary Supplement Formulation Consultant Specializing in Formulating Scientifically Backed Dietary Supplements;High-End Research, Supplements, New Custom Formulations in All Applications.Summary Pharmaceutical formulations with expertise in dietary supplement formulation. All high-end research-based supplements, including herbals, organic, CBD, women and children health, nootropics, sports nutrition, probiotic, energy blends and new custom formulations for all applications.  Dietary supplement formulation with ingredients that work on the human body in appropriate dosages. Modify existing formulas offering expert guidance for ingr...

Ph.D. Pharmaceutical-Nutraceutical Formulator and Consultant for Industrial Pharma and Nutraceutical, Tablets, Capsules, Health Foods, Soft Drinks, Diary, Snacks, Nuts and Seeds, Gums in Food Products, Pectins,Nutraceutical and pharmaceutical formulation and manufacturing.Formulating hemp Cannabidiol (CBD) products.Pharmaceutical Formulation Scientist with prior industry, FDA experience in CMC writing for small molecules and biologics for both FDA and EMA.Tablet and capsule formulation, manufacturing, trade secret infringement, product labeling, and patent evaluation.Formulation and manufacturing of food, nutraceutical, and pharmaceutical...

Ph.D. Biochemistry Food and Nutrition Expert. Food Emulsion Biochemistry and Physical Chemistry, Fermentation and Coagulation within Non-Dairy SystemsNutritional food and beverage product development, bridging between chefs, food technologists, protein chemists and biochemists, and executives.Industry research planning, methods development, rapid prototyping, product development management and troubleshooting, patent applications, product upscaling, co-packer and business-to-business relations, and brand ambassadorship to both businesses and consumers.Product-specific reduction and elimination of eggs and dairy ingredients in a variety o...

Beverage Manufacturing of over 15 Years: Multi-faceted Supply Chain Professional in Beverage Manufacturing Industry. Contract Manufacturing and Contract Development, Vertical Integration, EnterpriseSummary Diversified general manager with significant experience in the CPG (Consumer Packaged Goods) beverage sector. Excellent conceptual problem solver, people leader, and communicator. Demonstrated leadership over enterprise-wide transformational initiatives, manufacturing, packaging design, and sustainability. Focused Areas  Vertical integration of water, CSD (Carbonated Soft Drink), hot fill, retort RTD (Ready To Drink) coffee, a...

Extensive experience in toxicology, pharmacology, product safety, and regulatory standards.Consulting in toxicology and product safety evaluation and assessment to the following industries: OTC drugs, pharmaceuticals, cosmetics, personal care products, chemical household products, medical devices and biotechnology.Establish and manage product safety compliance, regulatory standards and approvals.Design and manage safety evaluation and toxicology research programs that meet industry standards and are successful in achieving regulatory approval.Consultation and scientific support for product liability and toxic injury.California Proposition...

Business & Academic Environments- Production & Operational Teams, Building B2B Industrial Companies in Plastics, Life Sciences Industries, and ISO 9001 AuditorSummary  Chief Technologist with the successful execution of production and operational teams in business and academic environments. Developed materials and products for B2B industrial companies, in plastics and life sciences industries. Deploying over 15 years of experience in processing plastics, chemicals, and downstream products including films and medical devices.  Author, composing and presenting, scientific papers, grant applications, Patent Inventor, and patent b...

A Creative Scientist with Proven, Leadership & Business Skills. Extensive Contributions to Top Brands for Fortune 10 Food Companies. Venture Capital Skills in all Phases of Business and Scientific AOrganic Chemist: Trained with deep knowledge and experience in nearly all food systems and technologies. Proficient in food chemistry, thermal analysis, statistical experimental design, polymer chemistry, food microstructure and all food macromolecules. Developed and taught curriculum on water in foods, coating technology, starch and hydrocolloids. Food Product Creator: Baked goods, beverages, teas, snacks, cereals, bars, nutritional supple...