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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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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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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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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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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Holly Scott
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Phone: 407-435-3734
Expertise in inspections of FDA regulated industries including biologics & human tissue operations, clinical trial monitoring, and dietary supplements |
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