Global Premarket Submissions

ComplianceAcuity was originally founded under the GlobalReg® Compliance brand with our global regulatory submissions expertise in mind. We are experienced navigators of worldwide premarket regulatory requirements, accustomed to keeping pace with today’s dynamic global regulatory environment. Because we understand what international regulators are looking for, and how they think, we have an established track record of achieving timely, efficient marketing authorizations from authorities all over the world.

Using our diverse international regulatory background, we’ve successfully secured international marketing approvals for over 10,000 devices. Our expertise minimizes additional information requests from submission reviewers, allowing us to be an invaluable asset to your company’s goals of achieving market entry on-time and under budget. ComplianceAcuity can skillfully direct, prepare, submit and steer to approval any of the following types of submissions:

Testimonials

“Thanks again for all your help!  I am amazed at how quickly you have gotten these submissions through the process!”

  • Director of Operations, Class II & III Devices

“Kevin is the consummate professional who goes above and beyond when the situation warrants. What I appreciated most about his expertise is that he can teach without lording it over you. If you are looking for an external consultant to help with those complex FDA, Health Canada, and/or European Commission regulatory issues, you will be well-served to have a conversation with Kevin Randall.”

  • Sr. Process & Quality Manager, Class II Devices
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Our Company Golden, CO 80402, USA