Staff Members With Expertise In
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John R. Godshalk MSE, MBA

CV

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Phone: 703-485-6139

Expertise in cGMP compliance, facility design and regulatory requirements, quality assurance, audits/inspections

Louise C. Johnson M.S.

CV

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Phone: 650-740-4750

Expertise in regulatory affairs for investigational and marketed small molecules and investigational biotechnology products

Eugene B. Johnston CQE, CQA

CV

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Phone: 919-657-0435

Expertise in quality management and regulatory compliance

Nadine M. Ritter Ph.D.

CV

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Phone: 240-372-4898

Expertise in analytical CMC technical and regulatory requirements and R&D/GLP/GMP laboratory quality practices for biotechnology products

Michael A. Trapani MS, MBA

CV

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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

Michael Gross Ph.D, RAC

CV

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Phone: 215-316-8394

Expertise in quality and regulatory affairs for drugs, biologics, medical devices, specializing in combination products.

Holly Scott

CV

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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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