Kerin Ablashi M.S.
|
Click To Contact
|
Phone: 240-683-0007
Expertise in project management, regulatory submissions |
|
|
|
Thomas J. Gerteisen Ph.D.
|
Click To Contact
|
Phone: 919-264-7860
Expertise in quality systems, process/product/materials specifications, test method qualification/validation, mock PAI audits, third party audits |
|
|
|
John R. Godshalk MSE, MBA
|
Click To Contact
|
Phone: 703-485-6139
Expertise in cGMP compliance, facility design and regulatory requirements, quality assurance, audits/inspections |
|
|
|
Melanie T. Hartsough Ph.D.
|
Click To Contact
|
Phone: 301-742-3665
Expertise in nonclinical pharmacology and toxicology and preclinical development of biologic products |
|
|
|
John J. Jessop Ph.D., MPH
|
Click To Contact
|
Phone: 540-776-0680
Expertise in pharmacology-toxicology, regulatory affairs and product development for biologics and drugs |
|
|
|
Eugene B. Johnston CQE, CQA
|
Click To Contact
|
Phone: 919-657-0435
Expertise in quality management and regulatory compliance |
|
|
|
David T. Lin Ph.D., MBA
|
Click To Contact
|
Phone: 301-299-2853
Expertise in CMC (quality), product development, and FDA submission requirements |
|
|
|
Ronald A. Marchesani
|
Click To Contact
|
Phone: 650-378-1303
Expertise in compliance audits, facility design evaluation and quality system development/evaluation/oversight for biotechnology products |
|
|
|
Reginald D. Neal
|
Click To Contact
|
Phone: 202-294-8543
Expertise in facility inspections, facility validation and regulatory requirements |
|
|
|
Peter Probst
|
Click To Contact
|
Phone: 301-831-3007
Expertise in GMP compliance; quality assurance; facility audits/inspections, facility validation & regulatory requirements; facility design evaluation |
|
|
|
Nanda K. Subbarao Ph.D.
|
Click To Contact
|
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. |
|
|
|
Ann Sutton MPH
|
Click To Contact
|
Phone: 303-903-2097
Expertise in CMC, regulatory and product development for vaccines and live biotherapeutic products |
|
|
|
Michael A. Trapani MS, MBA
|
Click To Contact
|
Phone: 908-359-9519
Expertise in GCP, GLP and GMP audits, regulatory compliance and quality assurance/systems for biological and drug products |
|
|
|
Darin J. Weber Ph.D.
|
Click To Contact
|
Phone: 206-940-3923
Expertise in regulatory strategy and CMC development for cell-based therapies and engineered tissues |
|
|
|
Larry K. Winberry Ph.D.
|
Click To Contact
|
Phone: 248-396-5818
Expertise in quality systems, manufacture and control, and product development for biological products |
|
|
|
Ruth Wolff Ph.D.
|
Click To Contact
|
Phone: 301-921-4160
|
|
|
|
Blair A. Fraser Ph.D.
|
Click To Contact
|
Phone: 240-477-7826
Expertise in CMC (quality), drug and biologic product development and FDA submissions. |
|
|
|
David Rouse M.S.
|
Click To Contact
|
Phone: 919-303-1624
Expertise in research, review and regulation of biological products within CBER and the biopharm industry. |
|
|
|