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Expert ID: 723693 Florida, USA

Expert in Pharmaceutical Science; Preformulation, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation

As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…

Expert ID: 735720 Texas, USA

Expert in Gamma Radiation

Board-Certified Radiation oncologist Six licenses (AZ, IL, FL, TX, NV, NJ) 6 years of experience in benefits management with requested services denied sometimes for good and sometimes for bad reasons. Graduated in 2000 from Washington University. Patient-oriented physician with superb…

Expert ID: 733385 Minnesota, USA

Expert in Pharmaceuticals: Formulations, Injectables, Topicals, Analgesics, Pharmaceutical Analysis

CORE SKILLS Instrumentation skills. APIs/preformulation: X-ray diffraction; Raman spectroscopy; HPLC (potency, degradants, purity, linearity, accuracy, precision, LOQ, LOD) with detection via UV-Vis, fluorescence, and conductivity; content uniformity, dissolution/elution incl. sustained- and immediate release formulations, paddle wheel apparatus; forced degradation incl.…

Expert ID: 718487 Illinois, USA

Expert in Sterile Processing Technology

ExpertKai Expert's formal training and industrial experience have provided him a solid foundation to design optimal heat sterilization processes for foods, pharmaceuticals, devices, biologics, and equipment. His activities in this field include low-acid canned foods, in-container or terminal heat sterilization…

Expert ID: 717438 Minnesota, USA

Expert in Packaging Economics, Supply Chain, Benchmarking, Products, Processes, Market Data, Design, Financial

Expert has both a theoretical background and hands-on knowledge of extrusion processes of all types, including coatings, lamination, and film production. He has broad experience with these processes and the corresponding equipment. He has worked on the production floor with…

Expert ID: 733713 Texas, USA

Expert in Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.

. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization…

Expert ID: 734924 California, USA

Expert in Medical Device Engineering

He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…

Expert ID: 731644 Minnesota, USA

Expert in Lasers and Electro Optics

Provide R&D, engineering, application, product development, 3rd party technical/service, employee training, due diligence research, safety and regulatory compliance of lasers. electro optics and light based instrumentation. As a laser and electro optic technology specialist I’ve been an ongoing engineering, application,…

Expert ID: 730891 Ohio, USA

Expert in Medchem, Biotech, Cytotoxic Agents, Nucleic Acid and SAR

As a chemist, I focus on how nucleic acids are modified, repaired, and agents that modify them. These aspects of nucleic acids are important in many fields. I have strong expertise in anti-cancer agents and currently am actively publishing in…

Expert ID: 730278 Alabama, USA

Expert in Medical Device Sterilization, Medical Device QA, GMP Audit, Supplier Audit, SOP\’s

Expert, Consulting Principal, is highly regarded in the medical device and sterilization industries. Areas of expertise include: medical device sterilization (Radiation and EO), quality systems development and assessment, sterilization management, medical device regulations, supplier auditing, internal auditing, nonconformity investigation and…

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