Fractional Regulatory Services and Strategy

Expert Guidance and Scalable Support for Biotech Success

Regulatory leadership is essential for biotech 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) provides flexible, high-impact leadership,
delivering senior-level guidance and execution without the long-term commitment or expense
of a full-time hire and is backed by a team of unparalleled experience in orphan drug and
advanced therapy regulations, specializing in both FDA and EMA 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.

We Forge Strong Regulatory Partnerships for Biotech

RareMoon supports biotech teams throughout the development lifecycle with unmatched
expertise in the biotech consulting space:

• Preclinical stage companies preparing for Investigational New Drug (IND) or Clinical Trial Applications (CTA) submissions within 12 months, seeking seamless transitions into clinical development.
• Clinical-stage organizations managing 1–2 active programs or expanding pipelines that
  need integrated regulatory planning and cross-functional oversight.
• Emerging and resource-conscious biotech startups needing immediate support for
  planning, execution, and compliance

Why Choose RareMoon’s Fractional Regulatory Services?

Our service model is built for biotech. We provide regulatory clarity, strategic direction, and
day-to-day execution –when and where needed.

• Holistic Solutions Tailored to Your Specific Needs. Real-time senior-level regulatory leadership in orphan drugs and gene and cell therapy programs without the financial burden of full-time hires.
• Real-Time Biotech Regulatory Consulting and Execution. Avoid delays by leveraging real-time guidance and hands-on execution tailored to your
  program’s needs.
• Seamless Access to RareMoon’s Subject-Matter Experts. Leverage RareMoon’s internal network of multi-disciplinary specialists.
• Regulatory Intelligence to Accelerate Development. From planning to action with a partner who drives deliverables

What RareMoon’s Fractional Regulatory Services Provide:

End-to-end support across all critical regulatory functions:

• Strategic Regulatory Planning, Strategy. Develop regulatory pathway and key messages, align on data packages, and prepare for agency engagement.
• FDA Meeting and Scientific Advice Preparation and Optimization. Prepare for and manage meetings with regulators to solicit actionable and meaningful
  feedback.
• Board & Investor Communication and Strategic Alignment. Articulate regulatory feedback, strategy, and milestones that build confidence and
  alignment.
• Risk Mitigation & Compliance Oversight. Proactively manage regulatory risks, timelines, and expectations across development

Engagement Models

We understand that your biotech company has unique needs. That’s why our model is designed
for flexibility. Contact Us to find out more. <NOTE: ‘Contact Us’ needs to be a link.>

Ready to Accelerate Your Biotech Journey?

Contact RareMoon today to discover how our fractional regulatory services can empower your
team.

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