Kerin Ablashi M.S.
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Phone: 240-683-0007
Expertise in project management, regulatory submissions |
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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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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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Holly Scott
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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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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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