Julia Barrett M.D., MPH
|
Click To Contact
|
Phone: 303-905-5383
Expertise in clinical product development, clinical trial design and execution, and FDA licensure requirements. |
|
|
|
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 |
|
|
|
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 |
|
|
|
Louise C. Johnson M.S.
|
Click To Contact
|
Phone: 650-740-4750
Expertise in regulatory affairs for investigational and marketed small molecules and investigational biotechnology products |
|
|
|
James G. Kenimer Ph.D.
|
Click To Contact
|
Phone: 703-739-5695
Expertise in regulatory strategy – FDA liaison |
|
|
|
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 |
|
|
|
Jim McIver Ph.D.
|
Click To Contact
|
Phone: 781-718-5734
Expertise in product management, development, manufacture, control and regulatory submission for biological products and bioassays |
|
|
|
Peter A. Patriarca M.D.
|
Click To Contact
|
Phone: 301-233-3220
Expertise in biological product development, clinical evaluation, and product lifecycle management |
|
|
|
Ronald A. Salerno Ph.D.
|
Click To Contact
|
Phone: 215-896-2067
Expertise in global regulatory strategy and registration for vaccines, biologics and drugs including application of pharmacogenomics and biomarkers for regulatory decision-making. |
|
|
|
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. |
|
|
|
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 |
|
|
|
Daniel P. Offringa
|
Click To Contact
|
Phone: 703-739-5695
Expertise in electronic submissions |
|
|
|
Holli S. Vaughan M.S., RAC
|
Click To Contact
|
Phone: 703-739-5695
Expertise in project management, regulatory submissions (paper and electronic), Orphan Drug Designations |
|
|
|
Michael Gross Ph.D, RAC
|
Click To Contact
|
Phone: 215-316-8394
Expertise in quality and regulatory affairs for drugs, biologics, medical devices, specializing in combination products. |
|
|
|
Blair A. Fraser Ph.D.
|
Click To Contact
|
Phone: 240-477-7826
Expertise in CMC (quality), drug and biologic product development and FDA submissions. |
|
|
|
Rebecca Spence Ph.D.
|
Click To Contact
|
Phone: 720-854-4874
Expertise in evaluating clinical data and communicating science through clinical, regulatory, and commercial documents. |
|
|
|