Liaison with Regulatory Agencies
ComplianceAcuity has a proven history of effective interaction with regulatory agencies such as the FDA. On behalf of our clients we routinely communicate both formally and informally with these agencies regarding submission reviews, pre-IDE meetings, general inquiries, etc.
“The biggest value ComplianceAcuity brought to the table for us was communication. Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly they got everyone in our organization on the same page and moving in the same direction.”
- CEO, Class II Devices
“ComplianceAcuity’s capabilities in managing the FDA review process are strong. Kevin would keep us updated at all times during his interaction with the FDA as our representative. He would ensure that we completely understood what we were up against. If we had an issue with some of the FDA requests, ComplianceAcuity would go to bat to ensure FDA understood our request to dispute certain requests and vice versa (helping us understand the FDA requirements).”
- QA Manager, Class II Devices
“I am confident that your knowledge, contacts in FDA, and your ability to interact with [our] personnel were instrumental in getting our approval rapidly.”
- Director of Operations, Class II and III Devices