Strategic Development and Representation for
Biotech, Device and Pharmaceutical Companies

(720) 746-1190 Tel
(720) 746-1192 Fax

For Media Queries Contact Joan Lawson at 720-726-7604

Our New Site is Coming Soon!

Our entire site is coming soon but in the interim here’s some brief information about who we are and what we do.

We're Your Pharma, Biotech and Device Partner - Experts in Regulatory Strategy, Clinical, CMC and Strategic Program Development

CBR is committed to providing clients with both strategic and technical consulting in the areas of FDA representation, strategic program development, clinical program development, process development and quality assurance oversight. We have been responsible for the approval of numerous drugs and biologics in the US since 2002.

Breaking News!
07-Jan 15, 4:00 PM EST - The ODAC advisory committee unanimously recommended approval for the first biosimilar in the U.S., filgrastim (Zarxio), by Sandoz. The vote was 14-0 on the following question: Question 3 – Does the committee agree that based on the totality of the evidence, EP2006 should receive licensure for each of the 5 indications for which US-licensed Neupogen is currently licensed?

CBR was able to listen to the entire committee proceedings and would be delighted to share information for those who were not able to log-in.

What We Do

We provide expert services in the following areas:

  • US & EU Regulatory Representation
  • Biotech Product Development
  • Process & Methods Validation
  • Nonclinical Development Programs
  • cGMP Training & Certification
  • RealTime™ Clinical Trial Oversight
  • Vaccine Development
  • Device & Combination Products

Our Partners: