Regulatory Support

NaviGo can provide strategic guidance, support and management of the critical regulatory relationship that is necessary for a successful clinical trial.  Our experts can assist you from early stage development through successful marketing applications and post-market compliance with industry proven regulatory strategies, submissions and regulatory agency interfaces.

Key Regulatory Services include:

• Regulatory Strategies
• Notifications and Reporting
• Regulatory agency liaison, from strategy development through panel presentations
• Pre-market applications including IDE, IND, 510(k), PMA, NDA
• Regulatory and Legal review of Advertising and Labeling