Auditing

To mitigate the risks of government investigations, prosecutions, and civil and criminal penalties, companies must understand and abide by:

  • PDMA
  • Anti-kickback Statutes
  • False Claims Act
  • FDAMA
  • FDA Guidances
  • OIG Guidances
  • State Regulations
  • Industry Standards

Porzio attorneys have extensive experience with the compliance, regulatory and product liability issues of our pharmaceutical, medical device and biotechnology clients.  We understand the investigative process, as well as the business concerns and legal issues that affect the industry.  Examples of functions we audit and assess include:

  • Sample Distribution
  • Interactions with Practitioners
  • Grants
  • Continuing Medical Education
  • Off-label Communications
  • Promotional Materials
  • Medical Publications
  • Medical Associations
  • Direct-to-Consumer Program