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Regulatory Filings & Operations

Comprehensive, Expert-led Regulatory Solutions

FDA and Health Canada

Preclinical / Early Development

  • Pre-IND/Pre-Submission Meeting Requests & Meeting Packages
  • Orphan Drug Designation (ODD)
  • Rare Pediatric Disease Designation (RPD)
  • Fast Track, Breakthrough Therapy, and RMAT Designation Requests
  • Pre-IND/Pre-CTA Planning & Gap Assessments

Clinical Trial Filings

  • FDA Investigational New Drug (IND) Applications
  • IND & CTA Amendments (e.g., protocol, investigator brochure, CMC updates)
  • Health Canada Clinical Trial Application (CTA)
  • Annual Reports and Development Safety Update Reports (DSUR)
  • Expanded Access INDs
  • Safety Reports (e.g., SUSARs, IND safety updates)
  • Health Canada New Substance Notification (NSN)
  • Pediatric Study Plans (iPSP)

Marketing Applications

  • New Drug Applications (NDA, 505(b)(2))
  • Biologics License Applications (BLA)
  • Accelerated Approval & Priority Review Requests
Request a Proposal

EMA, EU National, and Other Global Health Agencies

Early Engagement & Scientific Advice

  • Scientific Advice Requests (via EMA or National Competent Authorities)
  • Pre-CTA Meeting Requests & Briefing Book
  • Orphan Designation Applications (COMP)
  • Priority Medicines (PRIME) Applications
  • Pediatric Investigation Plans (PIP)

Clinical Trial Filings

  • Clinical Trial Application (CTA) Submissions via CTIS
  • Substantial Modifications to CTAs
  • EU/EEA Ethics Committee Submission Support
  • Trial Master File (TMF) Strategy and Compliance

Marketing Applications

  • Marketing Authorization Application (MAA)
  • Responses to List of Questions (LoQ) and Outstanding Issues
  • Orphan Maintenance Assessment Report
Request a Proposal

Services Related to Regulatory Operations

Our team delivers comprehensive regulatory support tailored for biotech and pharmaceutical companies preparing to engage the FDA or other global health agencies. We offer flexibility in our engagements, so whether you need comprehensive, end-to-end regulatory services or targeted, specific support, our team is prepared to help. 

From planning and initiating to producing regulator-ready documentation, our operational team is ready to guide you through every step of the regulatory process. Whether you need support for early-phase submissions or full registration, our team combines scientific proficiency with operational excellence to help you accelerate development timelines, as an extension of your team.

Regulatory Strategy, Planning, and Management

Authoring & Reviewing

Document Reconciliation

Submission & Life-Cycle Management

US Agent / EU Sponsor / Point of Contact

Agency Interactions

Testimonials

"You and the entire RareMoon team have been thoughtful, steady partners over the years, and I've learned so much from being in the room with you and the experts you've brought to the table. Most of all, I'll remember how you do what you do - your clarity, conviction, and kindness made you true partners along the way. Thank you for your support over the years, and I wish you both - and the RMC team - all the best."
VP, Finance & Operations
East Coast Immunotherapy Company
"This (IND) wouldn't have happened without RareMoon's sage advice!!!"
Dr. M.B., PhD
Mayo Clinic