Kerin Ablashi M.S.
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Phone: 240-683-0007
Expertise in project management, regulatory submissions |
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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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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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Michael S. Williams
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Phone: 703-216-7944
Expertise in regulatory and product development for viral products, specializing in all aspects relating to influenza virus vaccines |
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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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Ruth Wolff Ph.D.
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Phone: 301-921-4160
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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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