Experts in Orphan Drug and Advanced Therapy Regulations
We specialize in accelerating biotech development with clear, actionable regulatory direction.
At RareMoon, we deliver tailored regulatory solutions for biotech companies developing rare disease therapies, cell and gene therapies, and other advanced therapeutic products —where strategic precision, operational efficiency, and milestone achievement are directly linked to valuation, strategic partnerships, and patient impact. We specialize in securing critical designations, preparing for high-stakes FDA, EMA, and global health agency meetings, and guiding programs from preclinical through clinical development with clarity. Whether you’re preparing a first-in-human IND, managing an accelerated pathway, or facing complex regulatory challenges, RareMoon provides clear, actionable regulatory direction—from concept to clinic.
A Trusted Regulatory Partner
RareMoon is a trusted partner to biotech companies worldwide and is known for delivering regulatory clarity in high-risk, high-impact development programs.
With unparalleled experience focused on rare diseases, including cell and gene therapies, and advanced therapeutic products, RareMoon is recognized as a leader in niche regulatory consulting services. Our team comprises seasoned regulatory advisors, operational specialists, medical writing professionals, and subject-matter experts across drug development disciplines, each excelling in their specific discipline.
We’ve built our reputation by solving difficult regulatory challenges, de-risking complex development plans, and supporting companies whose success depends on regulatory quality and speed. From early-phase planning to pivotal submissions, RareMoon is the team biotech innovators call when the stakes are high and timing is critical. Our mission is to turn regulatory complexity into opportunity, and our success is a direct reflection of our clients’ success.
Flexible, High-Impact Expertise—Without the Overhead
RareMoon delivers an integrated regulatory services model blending deep strategic insight with hands-on operational execution for orphan drugs and advanced therapies.
With our unique and scalable approach, we provide end-to-end regulatory support tailored to accelerate your program.
- We operate with a nimble, expert-driven model.
- We embed seamlessly into your team, providing as much or as little support as you need, exactly when you need it.
- We prioritize, define, and achieve regulatory milestones.
- We lead and manage interactions with global regulators, including the FDA and EMA, to de-risk your development path.
- We advance integrated CMC, nonclinical, clinical, and regulatory strategies.
- We provide multi-disciplinary strategy to meet business and corporate objectives.
8,000+
350M+
Over 50%
1,000
Drug Approvals
