Our Team has Secured Over 200 FDA and EMA Orphan Drug Designations
RareMoon is the recognized leader and trusted authority in securing Orphan Drug Designation (ODDs) for biotech and pharmaceutical companies.
Securing ODD isn’t just something we do — it’s where we started and what we are known for. With over 200 successful FDA and EMA ODD submissions, including many for programs facing complex challenges or initial deficiencies, we have built a proven, repeatable approach that ensures our clients’ success. Once a client is ready to proceed, RareMoon leads the ODD process, which includes preparation, authoring, rigorous quality review, and submission.
With RareMoon, you gain a well-crafted, regulator-aligned submission and regulatory intelligence to precisely navigate critical decisions.
Regulated and “un-regulated” incentives
When secured early in development, an ODD from the FDA or EMA validates a program’s nonclinical proof-of-concept and unlocks significant regulatory incentives, including:
- Waived and reduced regulatory fees
- Market exclusivity
- Tax credits
Additional non-regulatory incentives we see regularly:
- Enhanced credibility for strategic partnering and fundraising efforts
- Heightened patient awareness
Beyond regulatory incentives, obtaining ODD early in development provides additional benefits. Programs with ODD gain enhanced credibility in strategic partnering and fundraising efforts and have been seen to increase patient awareness— essential for advancing rare disease therapies through development.
