RareMoon is a unique full service regulatory affairs and nonclinical sciences group focusing on the design and execution of orphan product development programs.

We are the leading US based rare disease regulatory firm, with a solid team of regulatory & scientific experts for both the EMA & FDA.

We work efficiently and transparently with your team. We align our experts with your project needs, offer targeted solutions, and ultimately decrease your timeline to achieving pivotal milestones.

Regulatory Affairs



RareMoon is a unique full service regulatory affairs and nonclinical sciences group focusing on the design and execution of orphan product development programs.

Nonclinical Development



With extensive experience in orphan product development, regulatory interactions and over 40 successful IND’s, RareMoon’s experts consistently offer nonclinical support and strategies with confidence.

Consultancy / Strategic Advice



Whether you are needing an application from start to finish, a detailed product development plan, or a simple review, we support you and your team.

Project Management



With little room for error and fewer resources to rely on, RareMoon understands project oversight will help your organization cut costs and manage risk.