Christine Brauer
Ph.D. ·
Rockville, Marylandregulatory affairs services for medical device manufacturers and combination products
assessing regulatory pathways for new products
developing regulatory strategies
meeting U.S. FDA requirements
preparing regulatory submissions
assessing preclinical and clinical testing requirements for new medical devices
negotiating testing requirements with FDA
preparing and presenting findings at professional meetings
aiding in the preparation of advisory panel meetings
regulatory affairs for diagnostic devices and therapeutic products
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oncology
neuro-protection
in vitro diagnostic devices
biotechnology-based therapeutics
FDA Expert
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