FDA Compliance and Submission Services

FDA Compliance and Submission Services

Our FDA consultants work with you to determine the best route to market for your product and support you throughout the entire FDA submission process.

Planning
• Assess existing information you have created that will support your submission
• Identify and prepare additional materials necessary for FDA review
• Identify studies and testing that might be necessary
• Plan FDA communications

Pre-Submission Activities
• Plan Pre-Submission meetings with the FDA, which might include conversations about:
-- Investigational Device Exemption (IDE)
-- Clinical Studies
-- Clinical Trials
-- Human Factors Validation
-- Safety Testing
-- Software Validation
-- System Verification & Validation
• Prepare protocols and manage projects related to Pre-Submission meetings
• Conduct Pre-Submission meetings with the FDA to answer open questions, such as whether a de novo pathway as a Class II device would be considered acceptable and to confirm if the proposed clinical testing is adequate.

Submission Filing
• Ensure the appropriate records and documents have been generated to support the PMA, 510(k) or de novo submission.
• Prepare the application
• File the submission