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Expert ID: 726401 New York, USA

Expert in Hydrogel Science and Technology for Drug Delivery, Medical Devices and Consumer Products

Expert’s major contributions are in microbial control of wide range of medical devices and pharmaceuticals. He has a background in chemical engineering and polymer science. He has decades of experience from numerous companies- large device and pharmaceutical companies to startups…

Expert ID: 726285 California, USA

Expert in E-beam Imaging Product and Material Development, Laser, FDA Radiation and Product Safety Compliance

Expert is a well-qualified professional with more than 15 years of experience in designing electronic products and materials for high kV electron beam and x-ray imaging applications . He has got extensive knowledge in image processing and analysis of the…

Expert ID: 726016 New Jersey, USA

Expert in Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization

His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition…

Expert ID: 725879 Illinois, USA

Expert in Biotechnology, Enzymes, Environmental Bioremediation, Regulatory Compliance

Expert has over 40 years of experience in both basic and applied Biochemistry (biochemical research and enzymology) and Biotechnology. He is very successful in finding flaws in published and spoken materials. His strengths are in the fields of physical biochemistry,…

Expert ID: 725868 Montana, USA

Expert in Quality Assurance, Regulatory Affairs, Marketing and Business Strategy for Life Sciences Industry

He has performed compliance audits to 21 CFR Part 11. He has developed qualification protocols to test systems compliant with 21 CFR Part 11. He has developed advertising campaigns, written copy for advertisements and managed the creative development of advertisements.…

Expert ID: 725448 Colorado, USA

Expert in Pharmaceutical Facilities, Pharmaceutical Manufacturing Processes, Facility FDA Compliance

In addition to having primary responsibility for numerous pharmaceutical construction projects over the last 15 years, Expert has also held several positions with pharmaceutical and medical device companies where he was responsible for the daily operations of facilities engineering, maintenance,…

Expert ID: 725173 Germany

Expert in Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC

Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles…

Expert ID: 725075 Minnesota, USA

Expert in Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing

12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…

Expert ID: 724877 India

Expert in Drug Discovery & Development Technology and Intellectual Property (Patents, Trade Marks, etc.)

He has had the Drug Discovery Department, as part of his role as Director R & D, at Wockhardt Limited, discover several new NCEs during the tenure of this position, which NCEs are more extensively described in a later section…

Expert ID: 724825 New Jersey, USA

Expert in In-Process Analytical, cGMP Auditing, Polymer Characterization, Analytical Lab Design and Management

Expert has 32 years of industrial analytical chemistry experience. For the last 24 years of that period, he headed the analytical R&D organization of International Specialty Products, a $1.7B specialty chemical company (as of 2007). In his time heading that…

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