Kerin Ablashi M.S.
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Phone: 240-683-0007
Expertise in project management, regulatory submissions |
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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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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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Andra E. Miller Ph.D.
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Phone: 301-320-9537
Expertise in CMC, regulatory and GMP requirements for cell and gene therapy products |
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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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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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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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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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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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