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Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in bringing products…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…
Package Development and Testing
Expert has over 25 years experience with the development, engineering, and troubleshooting associated with a variety of packages. She has developed and selected materials and components involving rigid plastics, cartons, and flexible packaging. She has designed and prepared specifications and…
Medical Device Design and Manufacturing: Laboratory Devices, Surgical Instruments, and Disposables
Expert has expertise in the design and development of laboratory devices, surgical instruments, and disposables for the biotechnology, pharmaceutical, medical device, electronic, cosmetic, and consumer product industries. Examples of products he has developed and/or patented are an I.V. disposable product…
Microbiology: Bacteria, Molds/Fungi – Identification, Quality Control, Remediation, Expert Witness
MICROBIOLOGY; BACTERIOLOGY; MYCOLOGY; MICROORGANISM IDENTIFICATION. Expert has expertise in the identification and control of microorganisms including aspects of sterilization, disinfection, and inhibition of microbes. He has extensive background in the application of control mechanisms and chemicals to all environments, including…
Biomedical Device Engineering
BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product…
Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare manufacturing industries, he works with about 30 worldwide…
Fermentation, Product Recovery, Bioprocess Scale-Up, Bioinformatics, Former ISO 9000 Auditor
Expert (pronounced moy-man, ) is a former certified ISO 9000 auditor. Expert advises on productivity and quality assurance improvements, preparations for current Good Manufacturing Practices (cGMP) for FDA compliance. As an expert user of mainframes, minicomputers and microprocessors, he is…