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Beaufort Advisors LLC
500 E. Main St., Ste. 1301
Norfolk, VA 23510 USA
Tel: 757/228-3250
Fax: 757/961-7479
Web: http://www.beaufortadvisors.com
E-mail: info@beaufortadvisors.com
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Corporate Overview
Beaufort Advisors provides full-service 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.
Beaufort Advisors combines regulatory compliance expertise with exceptional client service to deliver consistent, reliable and cost-effective results for our clients. Our service offerings include:
Regulatory Consulting
- Strategic planning for new products or product line extensions
- FDA submissions (IDE, 510(k), PMA, DMF)
- Response to FDA 483s
- FDA liaison
- U.S. agent services
- CE Mark assistance
Quality Assurance
- Quality system procedures development and implementation (QSR/cGMP compliance)
- Process and equipment validation
- Audits (internal and supplier) and staff training
- Mock inspections
- Corrective action response
- ISO 9001:2000 and ISO 13485 compliance
Software Validation
- 21 CFR Part 11 compliance
- Computer system validation and verification
- IT strategy development and review
- Technology audits, risk analysis and gap assessment
- Software integration and data migration
Clinical Trial Management
- Study design and protocol development
- Site evaluation and qualification
- Study management and coordination
- Data analysis, management and reporting
For More Information, contact us at (757) 228-3250 or info@beaufortadvisors.com.
Categories this company is listed under in the North American Suppliers Directory:
- R&D, Design, and Business Services: Clinical services (87 companies)
- R&D, Design, and Business Services: Consulting/Training services (385 companies)
- R&D, Design, and Business Services: Facility design (62 companies)
- R&D, Design, and Business Services: FDA submissions (171 companies)
- R&D, Design, and Business Services: ISO 9000 certification services (75 companies)
- R&D, Design, and Business Services: Manufacturing capabilities (383 companies)
- R&D, Design, and Business Services: Process validation/QC (238 companies)
- R&D, Design, and Business Services: Software development/Validation (224 companies)
