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Expert ID: 730118 Washington, USA

Expert in Hospital Tests and Kits, Clinical Chemistry, Coagulation, Serum Controls, Manufacturing Processes

Expert received his PhD in Biochemistry (Enzyme kinetics on NAD kinase in 1981), where he proposed a mechanism, Rapid Equilibrium Random with two dead end complexes for the enzyme, using enzyme inhibition studies. He was able to apply this knowledge…

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: 736123 Indiana, USA

Expert in Medical Device Quality Assurance and Regulatory Compliance

Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…

Expert ID: 732853 India

Expert in Cosmetic Manufacturing

• Successfully Handled a new range of Ayurvedic Manufacturing Factory from the scratch. Efficiently Managed a Factory with 400 man power. • Managed Five 3rd party manufacturing plants successfully. • Successfully Handled Flavour & Perfume Blending unit. • Setting up…

Expert ID: 731591 Colorado, USA

Expert in Global Procurement, Chemical Engineering, Manufacturing, Chemicals, International operations,

With over 17 years of experience managing new product development teams, Expert is currently Vice President of Research and Development. He is responsible for strategy, the new product pipeline, project management, resource allocation, product innovation, and intellectual property. His team…

Expert ID: 731331 Illinois, USA

Expert in CGMP,Pharmaceutical Manufacturing and Operational Excellence

Expert has over thirty (30) years of experience in the area of pharmaceutical manufacturing, pharmaceutical research and development, outsourcing, operational excellence and cGMP. Expert has broad ranging experience in pharmaceutical development, manufacturing and outsourcing that includes basic research in the…

Expert ID: 730122 California, USA

Expert in Pharmaceutical Formulation, Drug Delivery, CMC, NDA, and Formulation Patents

Expert has developed multiple immediate release and modified release oral formulations at ALZA Corporation and at Transcept Pharmaceuticals. Many of these formulations have been commercialized including Invega (OROS paliperidone) and Exalgo (OROS hydromorphone). Recently, Expert was instrumental in developing a…

Expert ID: 729135 India

Expert in CRO in Medicinal Chemistry, Pharmaceutical Chemistry, API, CRAMS, Speciality Chemicals, Training

Expert received his PhD in synthetic organic chemistry from the University of Hyderabad. He has 2 years of post-doctoral experience in synthetic and physical organic chemistry from University of Houston. He also worked on chiral polymers and energetic materials during…

Expert ID: 728891 California, USA

Expert in Pharmaceutical Product Development, Analytical Chemistry, Material Science, Process Development

Expert has extensive experience in pharmaceutical product development, particularly in developing drug/medical device combination products. He has over 15 years relevant experience in the pharmaceutical industry, highlighted by the launch of an anticipated $1B/year annual revenue drug/device product. Expert is…

Expert ID: 728603 Massachusetts, USA

Expert in Chemistry R&D and cGMP Manufacturing, Pharmaceutical Development

Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral…

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