Strategic Development and Representation for
Biotech, Device and Pharmaceutical Companies

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

Here’s a brief overview of 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.


FDA issued revised Form 1571 and Form 356h in April 2018 The 1571 form is substantially different in many fields.The new Block 7B on the 1571 now requires inclusion of a SNOMED CT clinical indication disease term. If you are a current client, or someone interested in learning more about SNOMED CT, feel free to call CBR Regulatory Affairs at 720-746-1190 for more information. FDA has prepared a short PowerPoint presentation to also assist you please click here.

We are Expanding and We're Hiring!
CBR is growing! We have numerous opportunities for professionals at all levels. For more information, please click to visit our Careers page.

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: