RareMoon | Regulatory Affairs Email Format

Biotechnology ResearchMaryland, United States2-10 Employees

RareMoon | Regulatory Affairs is a biotechnology-focused consultancy that specializes in regulatory affairs for orphan drugs and advanced therapies. The firm provides strategic and operational support, including planning, writing, review, and submission of regulatory dossiers, with a focus on guiding global programs through complex regulatory pathways and coordinating CMC, nonclinical, and clinical activities. Its services are aimed at small to mid-sized biotech companies developing therapies for rare diseases, helping them navigate global regulatory requirements and interactions with authorities to enable patient access. Based in Baltimore, Maryland, RareMoon positions itself as a dedicated regulatory partner with experienced professionals who draw on extensive experience from managing hundreds of global agency interactions, and it highlights a collaborative approach that leverages the expertise of its broader practice. A recent development in the business landscape includes a strategic partnership announced in May 2026 with Franklin Biolabs to offer joint consulting packages supporting preclinical-to-clinical transitions.

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