Biologics/Stem Cell Treatments

Helping Biologic, Cellular and Gene Therapy Companies Advance Novel Therapeutic Technologies

Recent progress in cell and molecular biology, and improvements in our understanding of both stem and gene cell therapies have delivered us to a whole new frontier in medicine. The challenge is that these products are extremely diverse, each with their own biology and immunologic properties, often times with no predicate to guide regulatory or clinical pathways. HPA can provide expert assistance in overcoming these unique challenges.

For more than 30 years, HPA has been providing regulatory and clinical guidance to biologic, cellular and gene therapy companies through our proven technology development process.

A Truly Client-Driven Culture

Strategies and Pathways Are Critical

HPA has the experience to formulate the best regulatory, quality and clinical strategies for your company and get you on the most efficient regulatory and clinical pathways right away.

Speed to Market

HPA knows that time is money and often the difference between success and failure. So we focus on helping our clients speed up the whole process, providing:

Mutual planning procedures that ensure quicker client interactions
Swift familiarization with our clients’ processes, culture and capabilities, enabling the alignment of core competencies and eliminating redundancies
Maximized value to the client, through assembly of the proper team around each project
By ensuring ongoing communication and seamless interactions, HPA has established an unparalleled track record of happy, successful clients.
Reduction in start-up time and costs, by leveraging HPA’s broad industry knowledge and experience

Strong Understanding of the Requirements and Expectations of Regulatory Bodies

Because regulating agencies and industry standards continue to evolve, HPA constantly strives to be on the leading edge of those changes. Weekly interactions with regulators gives HPA insight and experience in dealing with and understanding these requirements.

Therapeutic Areas of Expertise

Aesthetic Indications/Devices
Biologics/Stem Cell Treatments
Wound Care
Cardiovascular Technologies
Diagnostics/Imaging
Orthopedic Implants
Cosmetic Treatments
General Surgery
Drug Delivery Systems/Combination Products
Ophthalmic Therapies

Bring Your Innovations To Market

HPA offers senior-led regulatory, clinical, and quality support for medical devices, combination products and biotech.

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:

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.