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Regulatory Services
End-to-End Regulatory Strategy for Rare Disease Programs
RareMoon provides comprehensive regulatory consulting services to biotech and pharmaceutical companies developing therapies for rare diseases. Our team of experienced regulatory professionals works across the full spectrum of drug development, from preclinical strategy through marketing authorization, with deep expertise in orphan drugs, gene therapies, cell therapies, and biologics.
Whether you need a fractional regulatory leader to guide your program, expert support for an orphan drug designation application, or strategic preparation for a pivotal FDA meeting, RareMoon delivers clear, intentional regulatory strategy and the hands-on expertise to execute on it.
Our Regulatory Services
Fractional Regulatory Services
Senior-level regulatory leadership and strategic guidance on a flexible basis, without the commitment of a full-time hire.
Orphan Drug Designations
Expert guidance for FDA and EMA orphan drug designation applications with an unmatched track record of success.
Nonclinical
Nonclinical regulatory strategy for rare disease programs, including toxicology and pharmacology study design for IND and CTA submissions.
CMC
Chemistry, Manufacturing, and Controls strategy for biologics, gene therapies, cell therapies, and small molecules.
Clinical
Clinical regulatory strategy tailored to rare disease drug development, from first-in-human studies through pivotal trials and marketing applications.
Health Agency Meetings
Strategic and operational planning for FDA, EMA, and global health agency meetings, from Pre-IND through pre-submission.
Regulatory Filings & Operations
Strategic preparation and execution of IND, CTA, BLA, NDA, MAA and global regulatory submissions.
Publishing & Submissions
eCTD publishing, quality control, and submission management to ensure compliant, on-time regulatory filings.
Regulatory Designations
Strategic support for FDA and EMA expedited program designations including Breakthrough Therapy, RMAT, Fast Track, and PRIME.
Ready to Accelerate Your Regulatory Strategy?
Contact us to discuss how RareMoon's regulatory expertise can support your rare disease program from preclinical development through approval.