Health Policy Associates’ experience as a third party auditor for FDA Application Integrity Policy (AIP) is without peer in the industry. Since 1993, HPA Inc. has served as an independent auditor for FDA data integrity cases involving more than 35 separate submissions. No other firm can match this level of experience.
Chosen for nearly two dozen FDA data-integrity audits.
Built for inspections, not just enrollment.
Decades guiding high‑stakes medtech and biotech programs.
Health Policy Associates fully understands that companies involved in application integrity matters have both data integrity and compliance issues, as well as larger corporate management issues, each of which requires successful resolution.
Our services include:
Health Policy Associates has served as an independent review organization (IRO) under U.S. Government consent decrees and has been able to defer prosecution agreements by evaluating a company’s programs and systems regarding reimbursement and physician payments.
Our IRO services include:
You can find plenty of partners to run site visits, collect data, or assemble slides.
HPA is different: we are a senior‑led, FDA‑focused team built to help you:
And we do it all with a stable team and predictable budget.
If you’re carrying the pressure of an FDA setback, a critical submission, or a high‑risk trial, you don’t have to navigate it alone.
