Challenge #4: Achieve orphan drug status

We can guide your rare disease drug to orphan drug status

Premier Research can consult with you to determine if your product meets the criteria for orphan status in the U.S., European Union, or both regions — and if it does, we can guide you through the application process.

If your product’s eligibility for orphan status is borderline, our regulatory professionals can identify and present relevant data to maximize your chances of approval. We can also support the regulatory activities associated with orphan drug development, including EMA scientific advice meetings, FDA and advisory committee meetings, and preparation and submission of the final orphan drug applications in the U.S. and Europe.

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