Who is Azimuth Compliance Consulting?

Azimuth Compliance Consulting, founded in 2017, focuses on people, process, technology and culture. What makes us different from our competition is that we do not focus on the software or the consulting, we focus on the needs of our client to find the right solution to their situation. It may be software, or it might be helping fix a process that no longer works, such as a quality issue or a vendor certification. We start by bringing industry leading experts to our projects. We examine the processes that are most concerning to you. And finally, when required, we look at how technology fits the process, not how the process fits the technology.

How do we do this. We start with the understanding of the regulations as they are applied, review the draft and published FDA guidance documents, and recently issued 483s and warning letters. This helps us to better understand FDA’s thinking so we can help you. We stay current on industry standards, such as ISO 9001 or 13485 to make sure nothing is missing, and most important we work to understand your business needs. Our clients speak for us. Most of our business is not found through our marketing efforts, but through our clients.