CBR was founded on these core principles:
To assist companies with strategic development of novel biotechnology and pharmaceutical products as a development partner.
To create an environment of learning and professional development.
To promote team-building within projects and programs, to better advance client goals and long-term staff development for both CBR and our clients.
CBR International was founded in 1999 as Colorado BioReg, with the original intent to help small- to mid-sized biotech and pharmaceutical companies effectively navigate FDA requirements and conduct cost-effective, scientifically robust product development programs. Since then, CBR has grown from a company of 6 consultants, focused on U.S. regulatory and CMC issues, to a company of 30-45 professionals working in quality, scientific, regulatory, and clinical affairs.
Our founder, Jeanne Novak, PhD, is a recognized authority in the areas of biotechnology, combination product, device, and pharmaceutical development. Click here to learn more about Dr. Novak and our current leadership team.
Who We Are Today
We are scientists, engineers, clinicians, and regulatory experts with a commitment to excellence, dedication to scientific learning, and a philosophy of team-building.
Our teams have the expertise to support projects over their entire lifetimes, all the way from preclinical development through approval and post-marketing. We take a thoughtful, measured, and dedicated approach to every client program.
What We Do
We are dedicated to providing comprehensive product development services to the biotechnology, pharmaceutical, and device industries worldwide. We work with clients to identify program pathways and strategies. We know that identifying goals and gaps, and asking the right questions, will result in cost-effective and timely product development.
Our expert staff is experienced in an all-encompassing range of indications for drugs, novel antibodies, recombinant protein therapeutics, small molecules, vaccines, cell therapy, devices, and combination products throughout all phases of program development (Phases I - IV) and commercialization. Our scientific, clinical, and program development expertise has resulted in numerous biotech, drug, and device approvals through FDA and other global regulatory authorities.
What Makes Us Different
We are unique among consulting organizations in that we embrace a team concept that extends beyond our own staff. For example, we include experts in various disciplines and work with our global partners to achieve the highest effectiveness. Most importantly, CBR team members integrate into client programs to become part of the client team and drive programs to success. Our team model provides for full awareness of program needs, appropriate expertise, knowledge redundancy, reduced costs, and highly-effective results. We strive for excellence and achieve client goals in every project.
What CBR Team Members Accomplished in the Last 18 Months:
- Currently U.S. Regulatory Representative for 42 dossiers (INDs, pre-INDs, NDAs, BLAs, and Orphan Drug Designations)
- Submitted 13 original applications: 1 BLA, 9 INDs, 1 NDA, 1 Orphan Drug Application, 1 Marketing Authorisation Application (EMA)
- Completed 400+ submissions to regulatory authorities (40+ paper, 360+ electronic)
- Attended 11 meetings with FDA and European regulatory authorities
- Supported 36 Phase 2 & 3 clinical studies
- Attended 3 scientific/technical conferences
- Presented 1 university seminar
- Supported 2 career fairs
- Competed in 2 10k races
- Participated in the Boulder Relay for Life and the Denver March for Science