Regulatory Services Focusing on Orphan Drugs and Advanced Therapies
Comprehensive Regulatory Affairs Services
RareMoon provides comprehensive regulatory affairs services to life science and rare disease companies, with expertise across small molecules, biologics, and a team focused on advanced therapeutic products, including cell and gene therapies.
We support sponsors at every stage, from IND preparation and accelerated pathway strategy to agency interactions and designation planning. Our team of subject-matter experts delivers regulatory strategy and execution with precision, working directly alongside sponsors to move programs forward.
Fractional Leadership Services
RareMoon's Fractional Leadership Services offer senior regulatory and clinical operations leadership for biotech and pharmaceutical sponsors, real-time advisement without full-time costs.
Learn More →Regulatory Filings
Strategic preparation and execution of IND, CTA, and global regulatory submissions.
Learn More →Orphan Drug and Expedited Program Designations
Proven track record in ODD & expedited program designations. RareMoon marries strategic internal processes, data, and agency expectations to maximize approval potential.
Learn More →Cell and Gene Therapy Consulting
Regulatory and development strategy for AAV, CAR-T, CRISPR, epigenetic platforms, and other advanced therapy and regenerative medicine products.
Learn More →Health Agency Meetings
Strategic and operational planning and support for FDA, EMA, and Global Health Agency meetings.
Learn More →Regulatory Operations & Publishing
Working directly with clinical, nonclinical, and CMC teams to keep regulatory dossier authoring and submissions organized, managed, and progressing toward regulatory milestones.
Learn More →One Team, Trusted by Industry Leaders
Long-standing team continuity means your program is guided by dedicated experts who have collaborated on hundreds of regulatory submissions, providing concentrated expertise that is rare in today's CRO landscape.
FDA/EMA Orphan Designations
Successfully secured for rare disease programs
Health Agency Meetings
Benefiting from regulatory action plans
RMAT Success Rate
Unmatched track record in regenerative medicine
Unique Assets Supported
Across all phases of development
Updated June 2025
Testimonials
"The RareMoon team brings exemplary regulatory insights, experience and a mission-focused collaborative approach to managing and navigating innovative treatments for rare diseases."
"You and the entire RareMoon team have been thoughtful, steady partners over the years, and I've learned so much from being in the room with you and the experts you've brought to the table. Most of all, I'll remember how you do what you do - your clarity, conviction, and kindness made you true partners along the way. Thank you for your support over the years, and I wish you both - and the RMC team - all the best."
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Partner with experts who understand the unique challenges of rare disease development.
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