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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…
Chemistry – Environmental and Health Issues, Plant and Food Products and Brain Chemistry
Expert received his chemistry training at the University of Toledo (B.S.), Case Western Reserve University (Ph.D.) and the Massachusetts Institute of Technology (NIH Postdoctoral Fellowship), and has been a professor of organic chemistry at a prestigious University since 2006. At…
Dairy, Food, Plant-Based Foods, and Global Category Management
16+ years working in various leadership positions with dairy and food companies, Expert has gained expertise in all major aspects of the dairy & food industry. His expertise is in management, sales and marketing, business development, product management & process…
Human Resources Industry
Expert in Corporate Librarianship, Career Development, and Federal Human Resource Management. Expert served in the Army Reserves for six years as a Human Resource Specialist. She is a service-connected disabled veteran that has navigated the Veterans Health Administration (VHA) for…
Formulation Chemistry
Spray drying expertise in volatile solvents and end-user food powder products. A lead formulation chemist with over eight years of experience in the area of the formulation. A talented chemist that excels in a high-performing multidisciplinary research environment in the…
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…
Industrial Design for optical systems
I have been designing rifle sights, Infra-Red cameras, and various other products for the last 30 years. I've designed a number of mechanisms that have been tested and used regularly in production and in combat. I was able to do…
Flexible Packaging
Expert's key expertise resides in applying his understanding of the molecular structure of polymers to design structures to cost effectively satisfy engineering requirements. He is a specialist in polyethylene and its copolymers and has a superior understanding of Nylon and…
Conveyors & Conveyor Systems: design, build & install
Industrial Engineer with a B.S. degree in Industrial Engineering from New Jersey Institute of Technology (class of 1972), a New Jersey Professional Engineer’s license (Mechanical Engineering issued November 19, 1981) (now retired) and has over 45 years of professional experience.…
Pharmaceutical Processing and Packaging
Expert has over 20 years of experience in engineering and technical services. He has lead teams of engineers working in development, material qualification process development/ qualification, as well as lifecycle management for both new and existing combination/ non-combination products. Expert…