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Synthetic Organic Chemistry, Pharmaceutical Chemistry, Enzyme Technology, Bioorganic Chemistry
Expert is a synthetic organic chemist with more than 30 years of experience in industrial R&D. He is an expert in Drug synthesis and development. Visited a Biotech Industry in Ho Chi Minh City, Vietnam to offer on-site consultancy on…
Industrial Automation, Advanced Process Control, Project Management, Applied Mathematics
Expert R. Expert has worked on software development for industrial control analysis and design. He has directed several projects in industrial plant automation. Expert has done and published research on uncertain linear systems described by state space equations. Expert has…
Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Pharmaceutical Research and Product Development, Formulation and Analysis
Expert has spent nearly 25 years at Employer, teaching undergraduate and graduate courses in controlled drug delivery systems, pharmaceutical solutions, drug stability, drug diffusion and pharmaceutical rate processes. Before coming to USP, he was a teaching assistant at University of…
Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the…
Corrosion and Metallurgical Failure Analysis
Expert notes that corrosion is a major problem that affects many industries. Expert has spent over forty years studying and solving corrosion problems in the construction, aerospace, defense, petroleum, utility and related industries. He was also the technical editor of…
Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals
Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst,…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…
High Purity Process Engineering
Expert specializes in providing independent technical services to critical process industries such as manufacturing of pharmaceutical products and other specialty chemicals where high levels of purity must be maintained. WATER-TREATMENT FILTRATION PROCESS; CONTAMINATION CONTROL. Expert provides support in process development,…