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Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in bringing products…
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,…
Bioprosthesis, Cardiac Valves, Biocompatible Materials, Cardiovascular Diseases, Biomedical Eng.
BIOMEDICAL ENGINEERING. Expert has expertise in biomedical engineering, particularly in the areas of prosthetics and implantable devices. HEART VALVE PROSTHESIS; CARDIAC VALVE. The bulk of Expert's research has been related to heart valve prosthesis. His work has focused on the…
Mixing, Pilot Plants, Scaleup, Atomization, Agglomeration, Evaporation, Heat Exchangers
Expert has extensive knowledge of mixing operations needed in the chemical, petrochemical, and biochemical industries. His knowledge includes the proper selection of effective mixing geometries and the power requirements needed by a mixing unit in either laminar or turbulent applications.…
New Drug Development and Approval
Expert has extensive experience in complying with requirements of that part of the Act pertaining to drugs as implemented by the regulations of the FDA The requirements affect the development of drugs from the initial stages of screening to final…
Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare manufacturing industries, he works with about 30 worldwide…