RareMoon Consulting Inc.  

Baltimore ,  MD 
United States

We work exclusively on orphan drugs and advanced therapies providing biotech partners with an integrated suite of strategic and operational regulatory services. Our regulatory team brings over 100 combined years of industry and consulting experience in orphan drug regulations and development. Made up entirely of Ph.D./MS-level/MD, senior regulatory strategists and mechanics, and all the passion in the world, they lead programs to success. Our Clients are those looking for strategic and operational support; someone who can be eyes-on and hands-on their program as and when needed; someone to help them navigate this complex regulatory pathway, and help them to decide when and how to submit their orphan applications, applications for accelerated approvals, and interactions with the Agencies. We plan, formulate questions, write, review, and/or submit. ­ - Regulatory operations ­ - Strategy & Development ­- Medical Writing ­- Publishing

 Show Specials

  • (Mar 29, 2024)
    RareMoon's CEO shared on ASGCT Podcast: Committed to rare diseases, the team's passion fuels philanthropy. Win a PRO-BONO ODD for new clients at ASGCT!

 Press Releases

  • (Mar 29, 2024)
    RareMoon COO, Chris Novashinski to give presentation on Geographical Considerations in Initiating Clinical Trials for AAV Gene Therapies through the regulatory lens.


  • Services
    We're 90% focus on advanced therapies has honed our expertise in guiding 52 gene therapy companies, 73 products, and over 200 projects through regulatory paths....