Senior‑led regulatory strategy and execution for medical devices, combination products, and device‑adjacent biotech programs with complex regulatory pathways.
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 (HPA) provides senior‑led regulatory consulting for medical devices, combination products, and device‑adjacent biotech programs that need a clear, defensible FDA path, with support for CE Mark and other key non‑US submissions when required.
If you’re under pressure from a recent FDA interaction, an upcoming submission, or a hard‑to‑classify product, we help you understand how regulators are likely to see your program, where your real evidence gaps are, and what needs to happen next so you can move forward with confidence.
1.
How will FDA see this product?
2.
Which pathway makes the most sense, and why?
3.
Where are the real gaps in our evidence and documentation?
4.
What exactly needs to happen next, across functions?
5.
How do we explain this plan clearly to leadership, investors, and FDA?
We provide you with a concrete regulatory plan: clear documents and working sessions that move your program from uncertainty to a path you can stand behind.
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.
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.
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.
A regulatory pathway opinion and submission map outlining your product’s classification, the likely FDA pathway, and the key submission types you should plan for (for example, Pre‑Sub/Q‑Sub, 510(k), IDE, PMA), along with high‑level timing and resource implications.
Some programs need more than the basics. When things are especially complex, we can extend our Regulatory Consulting services to include the following:
A deeper assessment of the specific regulated submissions you will need and the likely pathway, beyond the initial high‑level opinion (for example, a more detailed mapping of Pre‑Sub/Q‑Sub, IDE, 510(k), De Novo, PMA, and related variants for your program).
Strategic support for sponsors recovering from challenged or unsuccessful regulatory outcomes, including re‑drafting and repositioning prior submissions. This can include correcting misalignment with the FDA, recovering from failed or withdrawn submissions, and reworking Breakthrough Device Designation requests that were previously denied.
An in‑depth review and refinement of your draft submissions and supporting documentation for strategy, completeness, and “language risk,” including detailed redlines and alternative framing options where needed.
An IDE‑focused gap assessment for EU‑to‑US transitions that compares your existing CE Mark technical files and European data packages against U.S. IDE expectations and outlines the additional work required to secure IDE approval.
1.
We start with a short call to understand your product, current regulatory status, recent FDA interactions, key milestones, and urgency.
You get a candid view of whether HPA is a good fit and what type of regulatory consulting engagement would help.
2.
We review a small set of key documents (for example, your latest FDA letter or high‑level plan) to confirm we can help and to scope the work.
This lets us understand the situation without asking your team to assemble a huge data room up front.
3.
You receive a clear outline of the questions we’ll help answer, the depth of review, and the core deliverables.
We define how we’ll work with your team and provide a proposal with the scope, timelines, fees, and information on how scope changes are handled.
4.
Once engaged, we hold a kickoff to align on objectives, roles, and ways of working.
We then perform a more structured review of your FDA correspondence, strategy documents, relevant clinical and safety summaries, and, where relevant, EU/international market files.
5.
We develop or refine the regulatory strategy, confirm or adjust classification and pathway(s), map key submissions, and identify evidence and documentation gaps.
This becomes your FDA Path & Submission Map, Regulatory Gap Assessment, and Regulatory Action Plan.
6.
As you move into submissions and FDA interactions, we review your submission drafts and, when appropriate, provide extended support to sharpen briefing materials and prepare for meetings.
We also provide an Executive Summary for internal leaders and investors and can stay involved to interpret new regulatory feedback and keep the plan on track.
If you need more than regulatory support alone, we can extend the engagement into Clinical Trial Strategy and Execution, so your clinical operations stay aligned with your regulatory plan.
When you’re staring at an FDA letter, a pivotal submission, or a hard‑to‑classify product, the real risk isn’t just moving slowly. It’s moving in the wrong direction.
HPA brings senior‑led, audit‑grade regulatory judgment to your program so you can choose a defensible path, see your true evidence gaps, and move forward with a plan your team, leadership, and investors can stand behind.
