JuliaBarrett M.D., MPH
|
Click To Contact
|
Phone: 303-905-5383
Expertise in clinical product development, clinical trial design and execution, and FDA licensure requirements. |
|
|
|
AngelaBlackwell M.S.
|
Click To Contact
|
Phone: 704-450-9934
Expertise in preclinical testing and biocompatibility of devices and combination products |
|
|
|
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 |
|
|
|
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 |
|
|
|
Eugene B.Johnston CQE, CQA
|
Click To Contact
|
Phone: 919-657-0435
Expertise in quality management and regulatory compliance |
|
|
|
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 |
|
|
|
Andra E.Miller Ph.D.
|
Click To Contact
|
Phone: 301-320-9537
Expertise in CMC, regulatory and GMP requirements for cell and gene therapy products |
|
|
|
Reginald D.Neal
|
Click To Contact
|
Phone: 202-294-8543
Expertise in facility inspections, facility validation and regulatory requirements |
|
|
|
Peter A.Patriarca M.D.
|
Click To Contact
|
Phone: 301-233-3220
Expertise in biological product development, clinical evaluation, and product lifecycle management |
|
|
|
StuartPortnoy M.D.
|
Click To Contact
|
Phone: 703-466-0961
Expertise in developing successful regulatory strategies for medical devices across a wide range of therapies |
|
|
|
PeterProbst
|
Click To Contact
|
Phone: 301-831-3007
Expertise in GMP compliance; quality assurance; facility audits/inspections, facility validation & regulatory requirements; facility design evaluation |
|
|
|
Nadine M.Ritter Ph.D.
|
Click To Contact
|
Phone: 240-372-4898
Expertise in analytical CMC technical and regulatory requirements and R&D/GLP/GMP laboratory quality practices for biotechnology products |
|
|
|
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. |
|
|
|
AnnSutton 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 |
|
|
|
Michael S.Williams
|
Click To Contact
|
Phone: 703-216-7944
Expertise in regulatory and product development for viral products, specializing in all aspects relating to influenza virus vaccines |
|
|
|
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 |
|
|
|
RuthWolff Ph.D.
|
Click To Contact
|
Phone: 301-921-4160
|
|
|
|
Daniel P.Offringa
|
Click To Contact
|
Phone: 703-739-5695
Expertise in electronic submissions |
|
|
|
MichaelGross 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. |
|
|
|
CalleyHerzog
|
Click To Contact
|
Phone: 720-883-3633
Expertise in regulatory project management for all types of premarket submissions. |
|
|
|
Blair A.Fraser Ph.D.
|
Click To Contact
|
Phone: 240-477-7826
Expertise in CMC (quality), drug and biologic product development and FDA submissions. |
|
|
|
Joseph C.Fratantoni M.D.
|
Click To Contact
|
Phone: 301-919-7217
Expertise in providing clinical assistance with regulatory and product development matters involving biologics, with a focus on blood and blood-related products |
|
|
|
HollyScott
|
Click To Contact
|
Phone: 407-435-3734
Expertise in inspections of FDA regulated industries including biologics & human tissue operations, clinical trial monitoring, and dietary supplements |
|
|
|
StephenRhodes M.S.
|
Click To Contact
|
Phone: 301-579-3700
Expertise in developing successful regulatory strategies for medical devices and combination products |
|
|
|
DavidRouse M.S.
|
Click To Contact
|
Phone: 919-303-1624
Expertise in research, review and regulation of biological products within CBER and the biopharm industry. |
|
|
|