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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Eugene B. Johnston CQE, CQA
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Phone: 919-657-0435
Expertise in quality management and regulatory compliance |
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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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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 Probst
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Phone: 301-831-3007
Expertise in GMP compliance; quality assurance; facility audits/inspections, facility validation & regulatory requirements; facility design evaluation |
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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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