Orphan Drug Development

Patients living with rare diseases are eagerly awaiting your therapy. Let us help get your product in their hands, faster.

Cardinal Health Regulatory Sciences has the unique expertise to navigate the complex development and regulatory processes needed to accelerate orphan drug development. Our experts in rare disease drug development have worked with more than 40 orphan drug programs in just the past 5 years.

Whether it’s preparing your orphan drug designation request or regulatory application, consulting on an FDA expedited program, evaluating your humanitarian use device, or authoring your orphan grant request, we can accelerate your orphan drug’s speed to market.

Because we know that patients living with rare diseases have waited long enough.

Expediting orphan drug approval

Learn our best practices for successfully navigating expedited pathways for orphan drugs. Download our white paper.

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