Navigating the regulatory landscape is a challenging endeavor. Whether taking a new product to market or extending an existing product line, the path can be complex and time consuming. Beaufort Advisors can help you meet the challenges of getting a product approved and maintaining compliance after it is on the market.

We make it our business to stay on top of the continuously evolving regulatory requirements for medical products. We maintain contact with the U.S. Food & Drug Administration and other international regulatory agencies, and we have the knowledge, experience and training to help you streamline your processes and expedite product approval.

Regulatory Consulting Services
»	Strategic planning for new products or product line extensions
»	Development and submission of regulatory documents, including:
	· Pre-market notifications (510(k)s)
	· Pre-market approval applications (PMAs)
	· Investigational Device Exemptions (IDEs)
	· New Drug Applications (NDAs)
	· Abbreviated New Drug Applications (ANDAs)
	· Investigational New Drug Applications (INDs)
	· Biologic License Applications (BLAs)
	· Device Master Files (DMFs)
»	FDA 483 and Warning Letter action plans and responses
»	FDA liaison
»	U.S. agent services
»	CE Mark assistance

To discuss how Beaufort Advisors can help you achieve your clinical research and regulatory compliance objectives, please contact us at info@beaufortadvisors.com or call 757.383.6000 .