Staff Members With Expertise In
"FDA Regulatory Submission Preparation / Review - RAC submissions"
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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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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