We work exclusively in orphan drug regulations.
An eyes-on and hands-on virtual regulatory team exactly when you need us.
Regulatory Operations
Strategy & Development
Medical Writing
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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.

“When we needed expert assistance with our Orphan Drug Designation filing, we placed our trust in RareMoon. They were easy to work with, integrating rapidly and seamlessly with our team and needs. And they get results. We received Orphan Drug Designation for our first indication based on their submission. I highly recommend RareMoon.”

S.A., West Coast Gene Therapy CEO

7,500+

Rare Diseases

350M+

People Affected

50%

Affect Children

650

Orphan Drug Approvals

We don’t see regulations as a hurdle.

We see them as the runway to patient access and marketing.

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.

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FREE 1-hour regulatory consultation!

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