Over three decades, HPA has evolved into a senior‑led, FDA‑focused partner for regulatory, clinical, and quality support, helping complex medical technologies reach the U.S. market while also supporting CE Mark and other international regulatory paths when required.
Our team has guided high‑stakes medtech and biotech programs through critical milestones, including Application Integrity Policy (AIP) data‑integrity cases, pivotal submissions, and inspection‑ready clinical trials.
HPA provides a personal, adaptable, and comprehensive approach to solving complex problems on multiple levels.
The firm is built around a long‑tenured senior core team, with leaders who have worked together for many years and remain directly involved in delivery. This continuity reduces handoffs, preserves institutional knowledge, and provides sponsors with a stable counterpart as programs move from early strategy through execution.
Our methods are informed by HPA’s history as an FDA‑facing third‑party auditor in AIP and related data‑integrity engagements, where our findings and recommendations fed directly into FDA decision‑making. The same audit‑grade rigor now underpins our regulatory counseling, clinical trial operations, and inspection‑ readiness work.
We are highly specialized in bringing product development, regulatory, and clinically focused strategic thinking to clients throughout the world, and we regularly work with some of the most unique and complex products in development. Our experience includes clarifying regulatory pathways, planning and managing clinical programs, and addressing quality and manufacturing gaps that could affect approval, inspection outcomes, or potential transactions.
We maintain a connection with the medical device venture capital community, evaluating and managing investment opportunities and helping to identify promising, cutting‑edge medical technologies.
By combining regulatory and clinical expertise with product development and strategic insight, HPA supports both sponsors and investors in assessing risk and advancing innovations to market.
