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

Denis Orsinger LogoWeb design by Denis Orsinger