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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…
IVD Assays and Diagnostic Tests Development
Expert's areas of expertise include the following: IVD (in vitro diagnostics) clinical laboratory regulation molecular diagnostics blood assay diagnostic instrumentation assay development CLIA-88 (Clinical Laboratory Improvement Amendments of 1988) clinical laboratory regulation quantitative risk analysis (risk assessment) laboratory management GLP…
Microbiology, Biocides, Biotechnology, Renewable Chemicals, Bioremediation
Expert is a microbiologist with expertise in microbiology and biotechnology with 7 years of consulting experience advising large and small industrial clients as well as venture capitalists and investment groups on emerging technologies in areas such as biocides, biofouling, biofilms,…
Pathogen Detection, Rapid Methods, Food Preservation, Antimicrobial Effectiveness Testing, Herbs
Expert has extensive experience (20+years) in food microbiology research including molecular pathogen detection methods and antimicrobial effectiveness testing. She has provided technical leadership and contributed expertise to develop and evaluate DNA-based methods and immunoassays for detection of pathogens including E.…
Biotechnology, Biochemistry, Molecular Biology: Enzymology, Protein Biochemistry, Industry
As a researcher in plant molecular biology, he published scientific data relevant for genetic modification of crops. He generated and characterized genetically modified plants, and published these data in peer-reviewed scientific journals. This research, and tangential research, allowed him to…
Toxicology, Cyanide, Toxic Metals, Environmental Health, Risk Assessment
Expert MD is a physician specializing in the evaluation and treatment of patients who have developed injuries or illness as a result of chemical, physical or biological agents. She is Board Certified in: Toxicology – through the American Board of…
Virology, Drug Discovery, Diagnostics, Bioterrorism, and Vaccines
Expert (, pronounced "Berr-oo-in") has spent over 20 years in the pharmaceutical and diagnostics industries. During that time he has been involved primarily in viral vaccine and antiviral drug discovery, although he has also run general molecular biology groups primarily…