RareMoon Consulting

Executive Summary

RareMoon Consulting (RMC) is a UK-based regulatory consulting firm founded in 2019 that specializes in rare diseases and advanced therapies, including cell and gene therapies, biologics, and small molecules. The company provides strategic and operational support to navigate complex regulatory pathways such as FDA orphan drug designations, breakthrough therapy applications, and global submissions. With deep expertise in rare disease drug development, RMC helps clients accelerate timelines and achieve regulatory approvals. As the demand for specialized regulatory guidance grows, RMC is well-positioned to capture market share. The firm's London headquarters and post-Brexit positioning enable it to offer tailored services for both FDA and EMA regulations, making it a valuable partner for developers of therapies addressing underserved patient populations.

Upcoming Catalysts (preview)

• Q3 2026Client Cell Therapy Approval Decision65% success
• H2 2026Strategic Partnership with CRO70% success
• 2027Expansion into US Market50% success