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Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…
Materials Processing
SIZE REDUCTION OF SOLIDS; GRINDING (COMMINUTION). Expert (prefers "Expert") has spent a significant portion of his career in size reduction technology, chiefly involving himself with the identification, selection, and qualification of crushing, grinding, and milling processes. He has developed processes…
Lipases, Biointerfaces, Instrumentation, Interaction of Drugs and Proteins with Lipids, Monolayers
LIPASES. Expert has spent most of his scientific career studying the regulation of lipases and other enzymes which function at oil-water interfaces. The emphasis of his work has been placed upon studying the role of lipid-lipid and lipid-protein interactions in…
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…
Biotechnology
APPLIED MICROBIOLOGY; BIOTECHNOLOGY. Expert is an authority in biotechnology, especially biotechnological principles for food, chemical, and pharmaceutical applications. He expends significant research efforts on the genetics of industrial organisms, with the ultimate goal of isolating, overproducing, and utilizing enzymes and…