Orphan drug regulatory affairs, gene and cell therapies, drug and biologics development consulting

"Providing biotech partners with an integrated suite of strategic and operational regulatory affairs services."

RareMoon specializes exclusively in orphan drugs and advanced therapies. Our expertise spans advising, developing, writing, reviewing, and submitting regulatory dossiers. Our regulatory team brings over 100 combined years of industry and consulting experience in orphan drug and gene and cell therapy regulations and development. We advise on the optimal timing and approach for submitting their orphan-drug requests, expedited program applications, and for interacting with health authorities.

Our mission

We work exclusively on orphan drugs and advanced therapies and our mission is to drive successful programs to pivotal milestones, benefiting Patients and Stakeholders.