We have been there in front of US and international regulators and behind the scenes providing system compliance audit and inspection support. Our consultants have many years of experience in the pharmaceutical and medical device industries. We know all of the common audit pitfalls and red flags and can quickly help you get prepared.
If you are facing an FDA inspection, EMA inspection, or customer audit, it’s not too late to get help.
How We Approach Software Compliance Audits
Our validation experts can help your project at any stage.