Health Agency Meetings

Strategic Planning and Support for
FDA, EMA, and Global Health Agency Meetings

RareMoon specializes in preparing companies for successful meetings with health agencies, from early-stage interactions to milestone-defining regulatory engagements. Whether you are approaching the FDA, EMA, Health Canada, or National Agencies, we provide end-to-end support, effective meeting styles, and ultimately, we help get you the answers you need to move your program forward.

Together, our team has supported dozens of regulatory meetings globally, including INTERACT, Pre-IND, End-of-Phase (EOP1/EOP2), Scientific Advice, and other pre-submission meetings.

We know how to formulate questions to obtain the answers you need and how to transform data into clear, actionable narratives, positioning your program to meet regulatory expectations.

End-to-End Meeting Support

Whether you need full scope or selected à la carte support, we can manage the entire process, submission of the meeting request, preparation of the package, meeting rehearsal and moderation support, attendance at the meeting, and post-meeting follow-up.

Meeting Strategy & Planning

We help clients identify the right meeting at the right time — from INTERACT and Pre-IND to Scientific Advice and pre-submission meetings with EMA, Health Canada, and other National Agencies. Our strategies ensure you are focused, prepared, and positioned to maximize value from your interaction.

Meeting Question Development

We help you frame questions to regulators that will lead to actionable feedback, focusing on areas that could unlock development efficiencies, regulatory flexibilities, or alignment on next steps.

Authoring, Reviewing, & Finalizing Meeting Packages

Our regulatory writers and subject matter experts draft, review, and finalize Briefing Packages that meet health authority expectations, highlight critical data, and clearly present development plans, questions, and proposed positions.

US Agent / EU Sponsor Services

We can act as your Agent (US), Sponsor (EU), and primary Point of Contact with regulatory agencies to ensure seamless communication.

Meeting Preparation, Attendance, & Post-Meeting Support

Whether you need regulatory strategists, operational support, or other functional subject-matter experts, we offer specialized, integrated solutions.

What You Get With RareMoon

RareMoon provides a seasoned team that has successfully led dozens of orphan drug and cell and gene therapies through key milestone meetings with the FDA, EMA, Health Canada, and EU National Agency, spanning early development through end-of-phase meetings.

Efficient Path to Key Milestones

We help you identify the right meeting at the right time—navigating interactions with FDA, EMA, and other agencies to keep programs moving toward INDs, CTAs, and pivotal trials.

Pragmatic & Hands-on Support

Our experts, including PhD, MD, and MS-level professionals, stay actively involved to ensure the team is well-prepared and well-supported.

High-impact Meeting Packages

We produce clear, compelling, and regulator-ready documents that lead to productive discussions and actionable feedback.

Integrated Regulatory Expertise

We work as an extension of your team to ensure alignment, preparedness, and confidence at every stage.