Beaufort Advisors provides full-service clinical research and regulatory compliance support to help medical product companies get to market as planned, on time and on budget. And once a product is on the market, Beaufort Advisors will provide the ongoing regulatory and quality support needed to maintain compliance.

Regulatory Consulting
»	Strategic Planning for new products or product line extensions
»	FDA submissions (510(k), PMA, NDA, ANDA)
»	Site management and monitoring
»	Response to FDA 483 letters
»	FDA liaison
»	U.S. agent services
»	CE Mark assistance
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Clinical Trial Management
»	Study design and protocol development
»	Site evaluation and qualification
»	Study coordination and management
»	Data analysis, management and reporting
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Quality Assurance
»	Quality system audits (internal and supplier) and staff training
»	Quality system procedures development and implementation (QSR/cGMP compliance)
»	Process and equipment validation
»	Mock inspections
»	Corrective action responses
»	ISO 9001:2000 and ISO 13485 compliance
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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.
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