Strategic Development and Representation for
Biotech, Device, and Pharmaceutical Companies

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

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 versions of Form 1571 and Form 356h in April 2018. The new Form 1571 is substantially different in many fields. 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 presentation to assist you: please click here [PDF].
(Posted 16 May 2018)

New Job Posting - Director of Regulatory Affairs
The Director of Regulatory Affairs will be responsible for the leadership and oversight of the Regulatory Affairs Department and a staff of 6 to 10 professionals. The Director will be responsible for the day-to-day planning and oversight of all consulting assignments and client deliverables from CBR Regulatory staff as well as development and maintenance of CBR Regulatory Systems. This position has a career progression to Senior Director of Regulatory Affairs and Vice President of Regulatory Affairs. Competitive salary and benefits. If you are interested in applying for this position, please send a cover letter and resume to

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:

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