Regulatory Compliance
FDA scrutiny of AI in drug development is intensifying. We identify representation gaps before they become regulatory hurdles — giving your compliance and R&D teams confidence that your AI tools will stand up to scrutiny.
Purposa Health — AI Health Compliance. Built for Every Patient.
AI Health Compliance for Pharma and Biotech
Every Patient. Every Population. Verified.
Purposa Health audits the AI tools and clinical datasets used in drug development to verify their credibility for regulatory use — including equitable performance across every patient population your product will treat. We surface representation gaps before they become submission risk.
- Pharma experience
- 25+ yrs
- Our focus
- AI Health Compliance
- Time to act
- Now
Why Purposa
AI is reshaping drug development.
AI tools now shape which medicines advance, how trials are designed, and which patients get found. Under FDA's Good AI Practice framework, any AI tool supporting a regulatory decision must demonstrate credibility for its context of use — and a tool built on data that doesn't represent the full patient population can't demonstrate equitable performance where it matters.
That's not just a scientific gap; it's regulatory liability. Purposa Health closes it — through independent audit, regulatory-grade methodology, and documented findings your regulatory and legal teams can defend.
"Every patient population deserves AI that was built to earn their trust. Purposa ensures that it was."
Patient Science
Every patient deserves medicine developed on data that reflects their biology, their population, and their lived experience. We hold the AI tools driving drug development accountable to that standard.
Accountability Partnership
We are not a vendor. We are a thought partner. Built on 25+ years of pharma executive experience, Purposa brings peer-level accountability to every engagement.
How Purposa Works
Engagement Types
Every engagement begins with a confidential conversation. We meet you where your AI compliance exposure lives.
01 — Tier 1
The Purposa AI Population Audit™
A credibility audit of the AI tools and clinical datasets in your pipeline — verifying equitable performance across patient populations against FDA Good AI Practice standards.
View The Purposa AI Population Audit™ details →02 — Tier 2
Remediation & Design Advisory
Close representation gaps and build equitable AI practices into your development pipeline.
View Remediation & Design Advisory details →03 — Tier 3
AI Compliance Governance
Build sustainable governance infrastructure ahead of evolving FDA requirements.
View AI Compliance Governance details →04 — New
NewAgentic AI Governance
Audit autonomous AI systems operating in drug development and clinical research environments.
View Agentic AI Governance details →Who we serve
We work with leaders who are asking the hard questions.
Chief Digital Officers
Deploying AI tools fast and need independent validation before regulatory deadlines hit.
Chief Medical Officers
Patient advocacy partners are questioning whether your AI reflects the patient populations your drug is designed to treat.
Regulatory Affairs Leaders
An IND or NDA submission includes AI-assisted analysis. You need a defensible representation and performance narrative before it goes to FDA.
Community Is Our Standard
AI compliance without community voice is just paperwork.
Purposa Health's community pillar — Purposa Learns, Purposa Activates, and Purposa Voices — ensures the patient populations most affected by representation gaps in clinical research help shape what equitable AI performance looks like in practice.
Learn About Our Community WorkPurposa Learns
Community Education Seminars
Purposa Activates
Community Day Events
Purposa Voices
Community Advisory Program
The mandate
The regulatory landscape is taking shape. Now is the time to assess.
FDA Good AI Practice
The FDA's draft AI credibility framework and the January 2026 FDA–EMA Guiding Principles establish the expectation that AI tools supporting a regulatory decision demonstrate credibility for their context of use — including equitable performance across patient populations. Sponsors are accountable for the tools they deploy, not just the data they generate. Final FDA guidance is anticipated and will sharpen these expectations.
EU AI Act
The EU AI Act sets audit, transparency, and ongoing-monitoring expectations for high-risk AI systems, including clinical decision support. Under agreements now moving through formal adoption, obligations for these systems phase in through 2027 and 2028 — giving sponsors a defined window to build defensible governance before the requirements bind. Transparency obligations begin applying earlier.
Enrollment Commitments
Regulator-required enrollment commitments for clinical trials create explicit linkage to the AI tools driving enrollment, patient matching, and protocol design. Most sponsors have not closed this representation gap yet.