See what some of our clients and colleagues are saying about AcKnowledge Regulatory Strategies...
We were able to get a very tricky 510(k), which required clinical data, cleared thanks to AcKnowledge. Whereas many consultants often want to fight with the FDA, AcKnowledge’s approach of working with the FDA made the whole process surprisingly pleasant.
AcKnowledge helped us with a tight timeline to get a submission to FDA, and we had a great interaction with our reviewers. Being part of a small start-up, we really appreciated that AcKnoweldge’s rates were within our budget. If you’re looking for regulatory experts, look no further!
Allison was our liaison during a face-to-face pre-submission meeting at FDA. Dealing with the Agency was very positive. Allison’s facilitation helped achieve the goal of the meeting: to get everyone in the room working collaboratively to bring our technology to market.
AcKnowledge RS was able to get our 510(k) cleared in under 90 days with no holds from FDA. The process was seamless.
Getting a file from Allison meant the FDA reviewer could expect a higher quality submission. Her files were simple to navigate and easy to understand. She was an excellent liaison between the company and FDA.
AcKnowledge RS has been instrumental in helping our company identify a regulatory strategy and prepare a submission to the FDA.
Allison has a superb grasp of medical device regulatory intricacies, is a quick-study on novel technology and most importantly, clear and definitive in her advice. Her deep subject matter knowledge and professionalism allowed us to get through difficult conversations with positive outcomes that led to the development of our significantly improved regulatory strategy. On top of her professional bravado, she is an absolute pleasure to work with!