Regulatory

AHRM Inc’s experience with US Regulatory Regulatory Affairs and Clinical Research Services allow us to provide our clients with the following:

Provide FDA regulatory strategy for device development and device classification

Act as FDA liaison
Submit your study protocol to FDA for a Pre-IDE review
Conduct pre-submission meetings
Work with the FDA to resolve any issues with the study approach
Provide advice and assistance and acts as a direct or indirect liaison between your company and FDA
Assist with clinical FDA negotiations meetings
Assist with device labeling requirements
Provide advice and support for preparation of 510(k), Investigational Device Exemptions (IDE), and Pre-market Approval (PMA) and CE Mark submissions and post-market requirements
Help or prepare you for FDA Advisory Committee meetings or physician advisory meetings
Assist with Import/Export Issues
Access to Global Network of Regulatory Affairs Experts: specifically China, India, Canada, UK and Latin America

Client Testimonial

AHRM, Inc. thank you so much for developing such a great web-site. The eCRF is the best that I have used. Your eCRF is arranged in a logical manner, which makes adding data a breeze. The drop-down menus have very explicit options, which I am sure will help streamline the data for the statisticians and definitely saves me time with data entry.

I am always impressed with the speed the pages load and the reliability of the web-site. I also like the interface between the Coordinator Site and the Pharmacy Site. This added electronic communication really helps with late-night randomization and dosing. I really like the tab created for adverse events. With a large interventional study with critically ill patients, there are a lot of adverse events. Having a quick, easy way to enter these events has made the chore much more tolerable.

Thank you for saving me time (which is always in short supply) with your friendly eCRF.

Melissa Lamb
Research Coordinator
University of Florida
Pediatric Critical Care