Application Integrity Policy

Health Policy Associates Inc.’s experience as a third party auditor for purposes of FDA’s Application Integrity Policy (AIP) is without peer in the industry. HPA Inc. has served as an independent auditor for FDA data integrity cases involving more than 35 separate submissions since 1993. No other firm can come close in matching this level of experience. AIP services include:

  • Developing independent audit plans for FDA review and approval
  • Auditing clinical sites
  • Writing integrity reports and managing FDA communications

Health Policy Associates Inc. fully understands that companies involved in Application Integrity matters have both data integrity and compliance problems as well as larger corporate management issues, each requiring effective resolution.

Health Policy Associates Inc. has served as an independent review organization (IRO) under U.S. Government consent decrees and deferred prosecution agreements by evaluating a company’s programs and systems regarding reimbursement and physician payments. IRO services include:

  • Developing a work plan for Office of Inspector General (OIG) review and approval
  • Performing Arrangements Review to ensure a company’s contractual and non-contractual arrangements do not violate the Anti-Kickback Statue
  • Preparing reports to review findings and submitting to OIG