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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Ronald A. Marchesani
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Phone: 650-378-1303
Expertise in compliance audits, facility design evaluation and quality system development/evaluation/oversight for biotechnology products |
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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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Ann Sutton MPH
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Phone: 303-903-2097
Expertise in CMC, regulatory and product development for vaccines and live biotherapeutic products |
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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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Darin J. Weber Ph.D.
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Phone: 206-940-3923
Expertise in regulatory strategy and CMC development for cell-based therapies and engineered tissues |
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Michael S. Williams
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Phone: 703-216-7944
Expertise in regulatory and product development for viral products, specializing in all aspects relating to influenza virus vaccines |
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Daniel P. Offringa
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Phone: 703-739-5695
Expertise in electronic submissions |
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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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Blair A. Fraser Ph.D.
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Phone: 240-477-7826
Expertise in CMC (quality), drug and biologic product development and FDA submissions. |
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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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