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ACTUALIZED SCIENCE EXPERTISE AND EXPERIENCE
Holds United
States Regulatory Affairs Certification (RAC)
FDA Reviewer for drugs (CDER) and devices (CDRH).
FDA Investigating
Officer for clinical studies, drug manufacturers and device manufacturers.
Certified Clinical Research Associate (CRA)
Directed
certification for CE, ISO 13485, and ISO 17025.
Experienced in commercializing academic research. Knowledgable in
FDA special programs and the needs of the pharmaceutical industry.
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