Find an Expert
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…
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…
Sterilization, Sterilizers
STERILIZATION; STERILIZER; AUTOCLAVE. Expert has over twenty years of experience in the design, production, and marketing of steam and gas sterilization equipment. His experience has covered small table top sterilizers through large bulk processing units. He has been responsible for…
Sterilization, Biomaterials, Tissue Banking, Medical Product Development, Polymer Toxicology
Expert K. Expert has spent 30 years in the medical products business, in which he developed sterilization processes such as ethylene oxide, gamma radiation, vapor phase hydrogen peroxide, plasma sterilization, aseptic processing, disinfection with formaldehyde, glutaraldehyde, and steam sterilization. Novel…