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Expert in Pharmaceutical Science; Preformulating, 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 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 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 in Sterile Processing Technology
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 of…
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 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 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 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 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 in Motion Sensors, Occupancy Sensors, Passive Infrared, Analog, Digital, Electronics & Proposals
Degreed, self-starting Electrical Engineer (BEE) who specializes in digital and analog circuit and system design and hardware, firmware, and software development. Skilled in the design, invention, and innovation of high technology security electronics. Extensive background in digital circuitry enhanced with…