Bringing Your Innovations to Market
HPA offers senior-led regulatory, clinical, and quality support for medical devices, combination products and biotech.
Our services are built for complex programs that depend on precise FDA strategy and execution.
Trusted in High-Risk FDA Integrity Cases
Chosen for nearly two dozen FDA data-integrity audits.
Audit-Grade Clinical Operations
Built for inspections, not just enrollment.
30+ Years in Complex Devices & Biotech
Decades guiding high‑stakes medtech and biotech programs.
Bringing Your Innovations to Market
Senior-led regulatory, clinical, and quality support for medical devices, combination products and biotech.
Built for complex programs that depend on precise FDA strategy and execution.
Trusted in High-Risk FDA Integrity Cases
Chosen for nearly three dozen FDA data-integrity audits.
Audit-Grade Clinical Operations
Built for inspections, not just enrollment.
30+ Years in Complex Devices & Biotech
Decades guiding high‑stakes medtech and biotech programs.
Trusted in High-Risk FDA Integrity Cases
Chosen for nearly three dozen FDA data-integrity audits.
Audit-Grade Clinical Operations
Built for inspections, not just enrollment.
30+ Years in Complex Devices & Biotech
Decades guiding high‑stakes medtech and biotech programs.
Who We Are
Health Policy Associates (HPA) is an FDA‑focused partner for regulatory, clinical, and quality support that helps complex medical technologies reach the US market, with experience supporting CE Mark and other international regulatory paths when required.
If you’re carrying the pressure of an FDA setback, a critical submission, or a high‑risk trial, we can give you a team that knows the terrain and treats the program as if it’s their own, from strategy through execution.
HPA operates at an entirely different level of rigor than many organizations in that space. Their team has shared knowledge, depth of expertise, and a critical lens.
They moved quickly, delivered under budget, and didn’t just analyze policy, but rather helped to translate it into something actionable that we can communicate confidently to investors and our team.”
— Erin Doyle
VP Marketing & Communications, SeeMedX
Why Medtech and Biotech Sponsors Choose HPA
Get Actionable Clarity
When the stakes are high, HPA turns ambiguity into clear findings, prioritized risks and next steps, so your team stops debating in gray areas and starts moving with conviction.
Defend Your Decisions Under FDA Scrutiny
HPA helps you make decisions and build evidence that holds up under FDA questioning—especially when data integrity, framing, or compliance concerns could derail your program.
Keep A Stable, Senior Team—and A Predictable Budget
Our senior-led team stays with you and manages scope changes transparently, so you avoid handoff drag, reduce rework, and control spend without the change-order spiral.
Audit-Grade Rigor
HPA’s approach was shaped in some of the FDA’s toughest data‑integrity situations.
HPA’s approach was shaped in some of the FDA’s toughest data‑integrity situations, when we were brought in as a third‑party to investigate whether trial data could be trusted as part of the Application Integrity Policy (AIP).
That experience helps us surface issues early and accurately through a data‑integrity lens, so you get clearer, more defensible findings and recommendations when the FDA starts asking hard questions.
Remediation & Repositioning
We help our clients recover quickly when an FDA letter or inspection finding throws them course.
HPA is the team sponsors call when things are off‑track because of data‑integrity concerns, failed or non‑viable trials, regulatory misclassifications, or serious quality and manufacturing gaps.
We help our clients recover quickly when an FDA letter or inspection finding throws them course, waste less time and money on dead end efforts, and protect deal values when quality or manufacturing issues threaten progress.
Choose the Support Your Program Needs
Regulatory consulting services
We help you turn regulatory uncertainty into a clear, defensible FDA path and prioritized action plan with submission materials your team and leadership can align around.
Clinical trial strategy & execution
We design and run inspection‑ready clinical trials using streamlined processes that keep quality high, timelines predictable, and budgets under control.
Senior‑Led Continuity
We’ve been around for over 30 years and have leaders who have stayed on the team for a decade or more.
Most sponsors have felt the pain of losing key people mid‑program. HPA was built to avoid that by anchoring delivery in a senior core team and designing the business around long‑term staff stability.
We’ve been around for over 30 years and have leaders who have stayed on the team for a decade or more. That means fewer handoffs, faster decision‑making, and more confidence that the team you start with is the one you’ll still be working with when things get complicated.
Budget Integrity
HPA is built around a different posture: tight scoping, early risk flagging, and disciplined change control to avoid the usual “change‑order spiral.”
In this industry, it’s easy to assume budget overruns are inevitable—especially after working with vendors whose fees expand through change orders once the work starts.
HPA is built around a different posture: tight scoping, early risk flagging, and disciplined change control to avoid the usual “change‑order spiral.”
With predictable spend and less budget volatility, you protect your runway with fewer surprise approvals and less internal friction from cost creep, easing milestone planning and investor conversations because you can talk about spend with confidence, not caveats.
— Roger Brown
Therapeutic Area Head, Musculoskeletal Repair, Mesoblast
Clarity and Confidence for FDA‑Complex Programs
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:
- Choose the right regulatory path and defend it.
- Design and run inspection‑ready trials that generate decision‑grade evidence.
- Stabilize off‑track programs with audit‑grade rigor and remediation horsepower.
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.