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Ann S. Brandt
Director @Pinnacle Healthcare Consulting
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WORK HISTORY
Director @Pinnacle Healthcare Consulting
Atlanta, GA, US
Valuation and Consulting services to U.S. and Global Life Sciences Companies, including Pharmaceutical, Medical Device, Biotechnology, and others. Specifically:Compensation system consulting in U.S. and globally, Valuation services including, HCP/KOL compensation, licensing, royalty payments, joint ventures, data acquisition/sales, and value-based services in the U.S. and globally.Our team also provides: Global regulatory assessment, planning and strategy, U.S. traditional and special 510(k), Investigational Device Exemptions (IDE), Pre-Market Approval (PMA), de novo preparation and submission, European technical file and design dossier preparation, preparation for Medical Device Regulation (MDR) implementation in Europe, and FDA, Notified Body, and ISO 13485 registrar audit preparation/participation. Our full range of Quality Services includes, establishment of a 21 CFR 820 and ISO 13•••••03 & 2016) Quality System, short-term or interim Quality System maintenance, and preparation and assistance with Medical Device Single Audit Program (MDSAP).
EDUCATION
The Kew-Forest School
High School
Texas Woman's University
Ph.D.
University of Maine
B.A.
SKILLS
ABOUT ANN S. BRANDT
With over 25 years at the forefront of valuation, compliance, and the application of…
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