Regulatory
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RareMoon Consulting

We are your virtual regulatory team.


We are senior regulatory experts offering FDA and EMA regulatory strategy and mechanics to global biotech companies developing orphan therapies.


SEE WHAT WE OFFER
7500+

Rare Diseases


>350 Million

People Affected


50%

Affect Children


Like us, our clients are driven by a passion and purpose to bring therapies to rare disease patients. We understand how designing a clinical trial and regulatory pathway to align with that purpose takes critical, creative, and reliable thinking.

650

Orphan Drug Approvals


We don’t see regulations as a hurdle. We see them as the runway to patient access and marketing.

FREE 1-hour regulatory consultation!