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Your Pharma, Biotech and Device Partner -
Experts in Clinical, Regulatory, CMC and Strategic Development
- Strategic Regulatory Submissions and Filings
- Analytical Method Development, Validation and Support
- Clinical Trial Oversight
- Preclinical Testing
- Facilities Design, Operation and Maintenance
- Process and Facility Validation
- Operations and e-Submissions
Jeanne Novak, Ph.D. founded CBR in 1999 as Colorado BioReg and primarily focused on regulatory and scientific support for drugs, devices, biologics and recombinant product programs.
CBR has developed numerous formal and informal alliances with other companies and individuals around the globe.
- CBR believes that becoming part of the client's program team is the most effective way to ensure the success of any program.
- CBR's work will be of the highest quality and customized to the client's needs.
- The client's program goals, timelines and budget are the priority.