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 News: Government Shutdown
During the ongoing U.S. federal government shut-down, the FDA will continue to perform
activities necessary to address imminent threats to human health. However, some FDA
functions will be unavailable during this period.
Please click here to read our news briefing.
(Posted 27 Dec. 2018)
FDA News: SNOMED CT
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 HR@cbrintl.com.
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.