As a leading orphan product consulting firm, RareMoon is trusted for both our understanding of the science and our knowledge of the hidden challenges of orphan product development and regulatory affairs.

Our track record of executing on successful regulatory applications is unmatched. Our ability to listen and comprehend your science and your goals, communicate effectively and professionally, and translate your key studies into a regulatory story is just what we do.

clipboard icon Regulatory Affairs


At RareMoon we believe a strong regulatory roadmap is key to driving your drug development program.

Our experts have proven track records of navigating the Agencies and driving successful orphan programs to pivotal milestones, benefiting Patients and Stakeholders.




Nonclinical Product Development


While strategies for the nonclinical development of your products follow collective regulatory guidelines, it is essential to design nonclinical orphan development program on a case-by-case basis and according to your specific product profile. Designing a most optimal program allows you to advance your product through various clinical stages and beyond.

Seasoned orphan product development experts at RareMoon understand that a well-designed nonclinical program will maximize your chances for clinical success.

Consultancy/Strategic Advice


We find some clients are needing a Regulatory Expert to join monthly development meetings, have the resources to author applications yet do not have the experience to confidently submit, or have designed a product development roadmap but are looking for experts to review and offer advice.

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

Project Management


Each project at RareMoon is closely managed by Professional Project Managers, allowing for maximizing responsiveness and adaptability.

While we closely monitor our own progress, having experience working with top industry CRO’s also means we have a network of close contacts and former colleagues allowing for us to also help you monitor your nonclinical progress. Combining both our Project Management experience, along with our vast network, allows for educated CRO selection, timely communication, and trusted science and study completion, keeping all projects aligned with your goals.