Thomas J. Gerteisen Ph.D.
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Phone: 919-264-7860
Expertise in quality systems, process/product/materials specifications, test method qualification/validation, mock PAI audits, third party audits |
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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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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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Ronald A. Marchesani
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Phone: 650-378-1303
Expertise in compliance audits, facility design evaluation and quality system development/evaluation/oversight for biotechnology products |
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Jim McIver Ph.D.
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Phone: 781-718-5734
Expertise in product management, development, manufacture, control and regulatory submission for biological products and bioassays |
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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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Nanda K. Subbarao Ph.D.
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Phone: 609-937-5892
Expertise in analytical CMC technical and regulatory requirements and R&D/GLP/GMP laboratory quality practices for biotechnology and drug products. |
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Ann Sutton MPH
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Phone: 303-903-2097
Expertise in CMC, regulatory and product development for vaccines and live biotherapeutic 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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Larry K. Winberry Ph.D.
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Phone: 248-396-5818
Expertise in quality systems, manufacture and control, and product development for biological 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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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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David Rouse M.S.
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Phone: 919-303-1624
Expertise in research, review and regulation of biological products within CBER and the biopharm industry. |
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