Julia Barrett M.D., MPH
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Phone: 303-905-5383
Expertise in clinical product development, clinical trial design and execution, and FDA licensure requirements. |
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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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Melanie T. Hartsough Ph.D.
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Phone: 301-742-3665
Expertise in nonclinical pharmacology and toxicology and preclinical development of biologic products |
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John J. Jessop Ph.D., MPH
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Phone: 540-776-0680
Expertise in pharmacology-toxicology, regulatory affairs and product development for biologics and drugs |
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Eugene B. Johnston CQE, CQA
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Phone: 919-657-0435
Expertise in quality management and regulatory compliance |
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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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David T. Lin Ph.D., MBA
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Phone: 301-299-2853
Expertise in CMC (quality), product development, and FDA submission requirements |
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Reginald D. Neal
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Phone: 202-294-8543
Expertise in facility inspections, facility validation and regulatory requirements |
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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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David J. Pepperl Ph.D.
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Phone: 301-987-5627
Expertise in nonclinical pharmacology and toxicology and preclinical development of biologic products |
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Nadine M. Ritter Ph.D.
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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 |
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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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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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Rebecca Spence Ph.D.
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Phone: 720-854-4874
Expertise in evaluating clinical data and communicating science through clinical, regulatory, and commercial documents. |
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