We are the leading US based rare disease regulatory firm, with a solid team of regulatory & scientific experts for both the EMA & FDA.
RareMoon is a unique full service regulatory affairs and nonclinical sciences group focusing on the design and execution of orphan product development programs.
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.