Strategic Development and Representation for Biotech, Device and Pharmaceutical Companies
CBR Biotech Strategies GmbH is a Global Regulatory Strategic Development Company located in the heart of the European biotech hub in Berlin, Germany. Our expertise along with our global alliances of experienced professionals is a valuable resource in helping International biotech, pharmaceutical and medical device companies. We specialize in providing clear guidance and well-defined corporate strategy to streamline overall product development from concept to post marketing. As your global regulatory and development advisors, we can support International program expansion and regulatory filings while working with U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and National Competent Authorities.
Extended Services with our Partners
Regulatory
Strategic Global FDA Representation
Clinical Development & Oversight
Strategic Clinical Development Programs
Quality/cGMP
FDA and EMA CGMP Training Programs
Scientific Affairs
Extensive Experience in CMC Development
Electronic Submissions
Full Service Regulatory Electronic Submissions