Practice Areas

Through strategic regulatory planning and tactical implementation, DuVal & Associates knows how to work, meet and succeed with the FDA in the following areas:

• Product approval strategy (510(k) vs. PMA, combination product approval path, etc.)
• Company and physician-sponsored clinical trials
• Manufacturing (cGMPs and QSRs)
• Part 11
• HIPAA compliance
• Post-marketing surveillance
• Inspections and recalls
• Development of training and compliance programs
• Investigations, audits, due diligence
• Product life-cycle analysis (anticipating competitive entries, Hatch-Waxman Act)
• Medicaid rebate statute
• Anti-fraud and abuse laws
• State-of-the-art marketing strategies including:
  • pre-approval communications programs
  • product launch campaigns
  • direct-to-consumer (DTC) advertising
  • appropriate and lawful off-label dissemination tactics
  • continuing medical education programs (CME)
  • peer-to-peer selling
  • public relations counsel
  • web site/internet strategy and content development, domestically and internationally
  • anti-kickback analysis