Fractional Regulatory Services and Strategy

Regulatory leadership is essential for biotech and pharmaceutical companies advancing from preclinical to clinical development or managing complex, active clinical programs. Yet, hiring a full-time Head of Regulatory Affairs or establishing dedicated Regulatory function(s) can be premature, costly, or misaligned with current needs.

RareMoon's Fractional Head of Regulatory (FHR) offers flexible leadership solutions through senior-level guidance and execution, without the long-term commitment or expense of a full-time hire. Your FHR is backed by a team with unparalleled experience in regulatory strategy, management, and submissions, as well as expertise in orphan drug and advanced therapy regulations, and specializes in global regulatory pathways. From strategic planning and regulatory submissions to hands-on support for agency interactions, RareMoon integrates seamlessly with your team to accelerate development and achieve regulatory milestones.

Strategic functional expertise is essential for biotech companies navigating early development milestones or working toward key regulatory and clinical objectives. However, assembling in-house teams across disciplines such as nonclinical, clinical, biostatistics, or medical writing can be premature, resource-heavy, or misaligned with stage-appropriate needs.

RareMoon's functional consulting model provides flexible, milestone-driven support across core development areas. Whether building a nonclinical development plan, authoring a statistical analysis plan (SAP), or assisting with protocol design, our discipline-specific experts deliver tailored strategies and hands-on execution, aligned to your stage and objectives, and backed by deep experience in rare disease and advanced therapy development within FDA and EMA frameworks.