RareMoon provides customized regulatory solutions to life science companies, with expertise across small molecules, biologics, and a team specializing in advanced therapeutic products, including cell and gene therapies.
Whether you're preparing for a first-in-human IND, planning for an accelerated pathway, or facing complex regulatory challenges, RareMoon provides clear, intentional regulatory strategy and the expertise needed to execute on it.
RareMoon's Fractional Regulatory Services offer leadership for biotech and pharmaceutical sponsors, real-time regulatory advisement without full-time costs.
Learn More →Strategic preparation and execution of IND, CTA, and global regulatory submissions.
Learn More →Proven track record in ODD & expedited program designations. RareMoon marries strategic internal processes, data, and agency expectations to maximize approval potential.
Learn More →Regulatory and development strategy for AAV, CAR-T, CRISPR, epigenetic platforms, and other advanced therapy and regenerative medicine products.
Learn More →Strategic and operational planning and support for FDA, EMA, and Global Health Agency meetings.
Learn More →Working directly with clinical, nonclinical, and CMC teams to keep regulatory dossier authoring and submissions organized, managed, and progressing toward regulatory milestones.
Learn More →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.
Successfully secured for rare disease programs
Benefiting from regulatory action plans
Unmatched track record in regenerative medicine
Across all phases of development
Updated June 2025
"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."
Partner with experts who understand the unique challenges of rare disease development.
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