Regulatory Designations
Unlocking Incentives and Accelerating Approvals.
This deliverable includes a comprehensive FDA Designation Action Plan, a structured, forward-looking assessment to identify, qualify, and leverage FDA acceleration mechanisms.
Key Benefits:
- Evaluation of program across all FDA designations and pathways
- Feasibility assessment
- Identify opportunities to stack and sequence designations
- Deliver a clear timeline and action plan
Supports development of medicines addressing unmet medical needs through enhanced scientific advice and regulatory support.
Key Benefits:
- Enhanced scientific advice
- Early dialogue
- Accelerated assessment
- Dedicated contact point
The FDA has implemented several programs that aim to foster collaboration and provide a flexible framework to rare disease drug developers.
Key Benefits:
- START (Support for Clinical Trials Advancing Rare Disease Therapeutics)
- RDEA (Rare Disease Endpoint Advancement)
- RDEP (Rare Disease Evidence Principles)
Expedited FDA review process that shortens the review timeline from the standard 10 months to 6 months for drugs that offer significant improvements in safety or effectiveness.
Key Benefits:
- 6-month review timeline
- Accelerated market access
- Available through Priority Review Voucher programs
- Strategic leverage for rare disease sponsors
(Last Updated June 2025)
Our Process in Securing Regulatory Designations
Regulatory designations like RMAT, Breakthrough Therapy, Accelerated Approval, and PRIME can de-risk development, unlock funding, and provide earlier access to regulators and markets.
At RareMoon, we specialize in securing these strategic designations. With hundreds of successful submissions and a high first-time success rate, our team knows how to navigate nuanced criteria, craft strong justifications, and position programs for success, before and after designation is granted. From eligibility assessment through post-designation planning, we bring clarity, momentum, and confidence to every step.
Our proven, internally developed process ensures programs are strategically positioned for success and data readiness when approaching regulators.
Feasibility assessments
Authoring
Reviewing and finalizing applications
Submission management
US Agent / EU Sponsor Services
Agency interactions
“Beyond securing your designation, our real value lies in helping you understand when to apply, how to position your data, and how to align your messaging for success.”~Sabrina, RareMoon's CEO
What You Get With RareMoon
High Success Rates
With streamlined processes and deep expertise, we expedite the process of securing ODD and crafting well-aligned applications that meet regulatory expectations.
Accelerated Timelines
With a team of highly skilled regulatory writers, we know exactly where to begin and how to navigate the process efficiently, ensuring swift and accurate document preparation from start to finish.
Expert Involvement
Our team of experts is ready to support, with MS, PhD, and MD-level professionals directly involved in your projects.
End-to-End Service
From initial feasibility assessments through to post-submission follow-up.
Related Services
Orphan Drug Designations
Expert guidance for FDA and EMA orphan drug designation applications.
Learn moreBreakthrough Therapy Designation
Navigate FDA Breakthrough Therapy Designation with expert strategic guidance.
Learn moreRMAT Designation
FDA Regenerative Medicine Advanced Therapy designation for cell and gene therapies.
Learn moreRare Pediatric Disease Designation
Strategic support for FDA Rare Pediatric Disease Designation and Priority Review Vouchers.
Learn moreIs your data designation-ready?
Schedule a consultation to explore designation opportunities.