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Organic Chemistry, Biocatalysis, Fermentation, Industrial Biotechnology, Chemical Process Development, Patent Liaison, Expert Witness for Patent Litigation
Expert has over 30 years of experience leading process development groups in a variety of fields. He employs biocatalysis and other biological methods to perform organic synthesis. In his current role, Expert offers executive-level technical strategy, project management, and due…
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…
Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing
Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…
Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Chemical Process Development in Refinery, Gas, Petrochemical, Renewable Energies and Water Treatment
Expert is a dynamic and multi-functional chemical engineer with 12 years' extensive experience in engineering, field engineering and construction and leadership of engineering and EPC in high-tech oil, gas and petrochemical projects. His diverse expertise spans from initial conceptual design…
Fluoropolymers and Surface Modification of Materials
He is an expert in fluoropolymers plant design, start-up, upgrade and quality improvement. He developed this specialty particularly at DuPont (U.S.). This expertise has been augmented throughout his career in USA, China and India start-up, plant upgrade and quality improvement,…
Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…
Wetlands, Wildlife, Storm Water, Erosion Control, Hydroponics, Aquaculture: Program and Project Management
Expert has a broad and comprehensive grasp of biological and ecological sciences. He specializes in land and water management. For land management, the services provided may range from aquaculture and hydroponic operations to environmental compliance operations. For water management, it…
Microbiology, Biocides, Biotechnology, Renewable Chemicals, Bioremediation
Expert is a microbiologist with expertise in microbiology and biotechnology with 7 years of consulting experience advising large and small industrial clients as well as venture capitalists and investment groups on emerging technologies in areas such as biocides, biofouling, biofilms,…
Concentrated Apple and Fruit Juice Production & Plant Management, Process Design, R&D
M.S. degree in chemical engineering, 27 years of experience in R&D, process design, quality systems and plant management mainly for concentrated apple and pear juice production, but also grapes and peaches. Responsible for processing more than 1.3 billion tons of…