Angela Blackwell M.S.
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Phone: 704-450-9934
Expertise in preclinical testing and biocompatibility of devices and combination products |
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John R. Godshalk MSE, MBA
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Phone: 703-485-6139
Expertise in cGMP compliance, facility design and regulatory requirements, quality assurance, audits/inspections |
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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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Stuart Portnoy M.D.
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Phone: 703-466-0961
Expertise in developing successful regulatory strategies for medical devices across a wide range of therapies |
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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 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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Calley Herzog
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Phone: 720-883-3633
Expertise in regulatory project management for all types of premarket submissions. |
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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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Stephen Rhodes M.S.
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Phone: 301-579-3700
Expertise in developing successful regulatory strategies for medical devices and combination products |
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