Publishing & Submission Services
Streamlined Regulatory Operations and Publishing Services
Publishing & Submissions
You'll receive end-to-end publishing and submission management, including eCTD formatting, quality control, and submissions to the FDA, EMA, and other global health agencies.
Regulatory Project Management
We will provide your company with hands-on regulatory project management, ensuring timelines, deliverables, and cross-functional coordination to meet regulatory milestones efficiently, such as Investigational New Drug applications (IND) and Clinical Trial Applications (CTA).
SME Applications (Europe)
We assist you or your Chief Financial Officer (CFO) with securing micro, small and medium-sized Enterprise (SME) status at EMA, unlocking fee reductions and other incentives essential for small biotech companies.
ATMP Classification (EMA)
We help determine if your product qualifies as an Advanced Therapy Medicinal Product (ATMP), and support the preparation and submission of ATMP classification requests to the EMA.
US Agent / EU Sponsor & Representation
We serve as US Agent for FDA submissions and EU Sponsor/Representative for EMA and national regulatory bodies, providing a direct line of communication with health authorities.
21 CFR Part 11 Compliance
RareMoon ensure systems and documentation meet FDA's electronic records and electronic signatures (ERES) compliance requirements, essential for inspection readiness and submission quality.
Regulatory Tracker Management
We establish and maintain regulatory trackers to monitor activities, commitments, timelines, and documentation — providing structure and visibility to clients and their teams.
What You Get With RareMoon
Trusted Partner for Global Submissions
RareMoon has experience with North American, European, New Zealand, and Australian submissions, giving you the confidence to meet global regulatory standards.
Regulatory Submission Record Keeping
Proper archiving of regulatory files from the earliest stages of development is essential to support regulatory continuity, strategic planning, and investor due diligence at all times.
Real Time Regulatory Tracker
Communication tracking is essential for future regulatory interactions. Real-time documentation ensures consistency, accountability, and readiness across all stages of development.
Operational Discipline that Meets Regulatory Deadlines
Meeting timelines are critical; meeting Agency deadlines is required. With integrity and diligence, we ensure your submissions are complete, compliant, and delivered on time, every time.