Julia Barrett M.D., MPH
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Phone: 303-905-5383
Expertise in clinical product development, clinical trial design and execution, and FDA licensure requirements. |
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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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James G. Kenimer Ph.D.
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Phone: 703-739-5695
Expertise in regulatory strategy – FDA liaison |
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Andra E. Miller Ph.D.
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Phone: 301-320-9537
Expertise in CMC, regulatory and GMP requirements for cell and gene therapy products |
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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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Kelly Reich M.S.
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Phone: 703-739-5695
Expertise in project management, regulatory submissions (paper and electronic) |
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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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