“Corporate compliance officers are…often the company’s ‘first responders’ and must focus on both proactive and reactive efforts to be effective. Proactive efforts need to emphasize the complementary goals of crime prevention and corporate ethical behavior. Reactive efforts measure how well a corporation reacts when it learns that questionable and potentially illegal corporate conduct has occurred.”
— US v. Caputo (7th Cir. 2008)

Practical solutions

Riordan Compliance specializes in providing prompt, cost-effective, high quality compliance solutions to start-up, small, and mid-sized biotech, pharmaceutical, and medical device companies.
  • Conducting Risk Assessments
  • Performing Gap Analyses
  • Reviewing and updating existing compliance programs
    in light of recent enforcement actions and evolving best practices
  • Developing and enhancing Compliance Programs
  • Developing and revising policies and procedures more
    • PhRMA Code Issues
    • AdvaMed Code Issues
    • Off-Label Promotion
    • Promotional Materials Review
    • Medical Education Grants (CME)
    • Investigator Initiated Trials
    • Medical Affairs' Handling of Requests for Off-Label Information
    • Medical Science Liaisons
    • Publications
  • Creating and providing training programs in the above key areas, as well as:
    • Basic compliance issues (including training for new hires)
    • Annual compliance reminder training to affected employees, focusing on current enforcement activities
    • Teaching basics of US laws to International employees in the US
    • Train-the-trainer programs
    • Training for executives
  • Developing effective and timely communications to employees on a variety of issues, including new governmental enforcement activities
  • Monitoring off-label promotion
  • Conducting investigations of non-compliance
  • Monitoring State Issues more
    • What the states require
    • Practical ways to comply with the laws
  • Preparing for compliance with the federal Sunshine Act

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