John J. Jessop Ph.D., MPH
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Phone: 540-776-0680
Expertise in pharmacology-toxicology, regulatory affairs and product development for biologics and drugs |
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Louise C. Johnson M.S.
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Phone: 650-740-4750
Expertise in regulatory affairs for investigational and marketed small molecules and investigational biotechnology products |
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Eugene B. Johnston CQE, CQA
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Phone: 919-657-0435
Expertise in quality management and regulatory compliance |
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Peter A. Patriarca M.D.
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Phone: 301-233-3220
Expertise in biological product development, clinical evaluation, and product lifecycle management |
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Ronald A. Salerno Ph.D.
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Phone: 215-896-2067
Expertise in global regulatory strategy and registration for vaccines, biologics and drugs including application of pharmacogenomics and biomarkers for regulatory decision-making. |
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Michael A. Trapani MS, MBA
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Phone: 908-359-9519
Expertise in GCP, GLP and GMP audits, regulatory compliance and quality assurance/systems for biological and drug products |
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Anne M. Zurbay RN, MSN, ND
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Phone: 303-589-4813
Expertise in medical writing, clinical safety, product development, and in authoring the clinical sections of marketing applications |
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Holli S. Vaughan M.S., RAC
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Phone: 703-739-5695
Expertise in project management, regulatory submissions (paper and electronic), Orphan Drug Designations |
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Michael Gross Ph.D, RAC
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Phone: 215-316-8394
Expertise in quality and regulatory affairs for drugs, biologics, medical devices, specializing in combination products. |
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Joseph C. Fratantoni M.D.
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Phone: 301-919-7217
Expertise in providing clinical assistance with regulatory and product development matters involving biologics, with a focus on blood and blood-related products |
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David Rouse M.S.
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Phone: 919-303-1624
Expertise in research, review and regulation of biological products within CBER and the biopharm industry. |
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