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Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product support, including analytical method development, process support,…
Pharmaceutical Solid Dose Forms
He has worked in the development and manufacturing of chewable tablets either for the delivery of locally (oral) acting drugs with a variety of excipients and basic tableting technology and in the development of medicinal candy products enclosing vitamins flavoring…
Technical Commercial Development Support, Technology Transfer Food Non-Food Ingredients, Obesity
Expert K. Expert is the Principal of a consulting firm and has over 35 years experience in R & D., marketing, operations, process development and quality assurance. Expert engaged and managed a consulting business with network of experts that range…
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…
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…
Powders and Tablet Manufacturing
Expert has developed tableting systems and products in the areas of pharmaceuticals, diagnostics, high-protein snack products, chlorine tablets, chlorine removal tablets, over the counter antacids, and vitamins. He has developed sustain release sugar bead systems and also via the use…
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…