Overview
Developing drugs for rare diseases presents unique challenges and opportunities. Orphan Drug Designation (ODD) offers significant benefits, including tax credits, fee waivers, and market exclusivity. We help you craft a compelling argument to demonstrate the rarity of your disease and the scientific rationale for your therapy.
Key Features
Our Process
Feasibility Assessment
Verifying your disease and prevalence data meet criteria.
Application Drafting
Compiling the scientific and epidemiological data into a robust application.
Submission & Follow-up
Handling the submission and responding to any agency information requests.
Frequently Asked Questions
Why Choose Us
- 7 years of market exclusivity (US)
- Tax credits for clinical testing expenses
- Waiver of NDA/BLA application fees
- Regulatory assistance and guidance
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Schedule ConsultationWhat Our Clients Say
"Securing orphan designation was critical for our investors and our economics. Adelphi's prevalence analysis was rock-solid, and the FDA accepted our application without any additional questions. The exclusivity alone makes our business model viable."
Michael Torres
CFO
Rare Disease Startup
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Pre-IND / Pre-CTA Meetings
Expert preparation and representation at critical health authority meetings.