For more than 30 years, HPA has partnered with orthopedic and regenerative medicine companies to successfully navigate the complex regulatory and clinical pathways required for FDA approval.
From first-in-human studies through pivotal IDE clinical trials and PMA, De Novo and 510(k) submissions, HPA provides the regulatory strategy, clinical expertise, and project leadership needed to efficiently move innovative orthopedic technologies from concept to commercialization.
Whether developing cartilage repair implants, bone regeneration technologies, spinal fusion devices, orthopedic biologics, soft tissue repair products, or combination products, HPA serves as a trusted strategic partner committed to reducing development timelines, minimizing regulatory risk, and maximizing the probability of FDA success.
HPA offers senior-led regulatory, clinical, and quality support for medical devices, combination products and biotech.
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.
