Regulatory Operations

How are we different from other regulatory operations firms?

We use a cross-functional "eyes on - hands-on" approach. The same senior-level regulatory scientists who strategize, also author and review every document we produce. This approach harmonizes your strategy and enhances the knowledge of knowing when and how to interact, with a global perspective in mind.

We write, review and/or submit.

  • Orphan-Drug Designation
  • Investigational New Drug (IND)
  • Regenerative Medicine Advanced Therapy Designations
  • Fast Track Designations
  • Breakthrough Therapy Designations
  • Rare Pediatric Disease Designations*
  • Neglected Tropical Disease Designations*
  • Medical Countermeasure Priority Review Vouchers
  • Annual Reports
  • *Subsequent Priority Review Vouchers
  • EMA
  • Orphan-Drug Designation
  • Priority Medicines (P.R.I.M.E.)
  • Pediatric Investigation Plans (PIP)
  • ATMP Classifications
  • Scientific Advice at every stage in development
  • Protocol Assistance at every stage in development
  • Early Interactions including Pre-submission Meetings
  • Early Interactions for Pediatric Medicines
  • IMPDs
  • Clinical Trial Applications
  • Innovation Passport (UK, MHRA)
  • Small and Medium-sized Enterprise (SME) Status
  • We plan, formulate questions, write, review, and/or submit.

  • Type A, B, C Meetings
  • Early Interactions including INTERACT Meetings
  • Post Breakthrough Designation Multidisciplinary Packages
  • Meetings with OOPD
  • Regulatory Project Management & Submissions
  • US Representation
  • EMA
  • Early interaction meetings / Pre-submission
  • Pre-CTA / Scientific Advice / Protocol Assistance at every stage
  • Briefing Meeting with the Innovation Task Force (ITF)
  • Prepare, publish/submit via required portals and gateways
  • EU Representation
  • GMO applications
  • Post-PRIME Meetings
  • Achievements (2016-2022)

      • FDA & EMA ODDs, Rare Pediatric Disease Designations154%
      • Expedited Program Designations23%
      • Agency Meetings50%
      • Pediatric Investigation Plans14%

    Regulatory Strategy & Drug Development

    We help clients unlock value by engaging effectively with regulators.

    As you seek investment, we create strategic drug development and regulatory plans that support your conversations and align milestones.

    Based on client objectives, we help prioritize, define and accomplish regulatory milestones by offering strategic and full operational support. We impress upon our clients how working collaboratively with regulators will allow for organization and preparation for nonclinical, clinical and regulatory strategy.

    We maneuver products through the regulatory framework, piloting the program into a position that is poised to accelerate into marketing as early as possible. Your success is our success and we go to work for it.

    Deliverables Include

    • Preparation and representation for EMA and FDA engagement
    • ODD Feasibility Assessments
    • Feasibility Assessments for expedited program applications
    • Strategic Review of applications
    • EMA/FDA Regulatory Positioning

    • Nonclinical Development support
    • CMC review and support (including IMPD and Module 3)
    • Epidemiology Forecasts
    • State-of-art Benchmark Analysis

    Our team combined, possess comprehensive knowledge of orphan drug development and a wealth of regulatory strategy from the hundreds of global agency interactions and work on successful orphan programs. Our sole focus in orphan drugs maintains our resourceful mindset and requires us to always consider novel strategies..

    Medical Writing

    Medical Writers compile, write, and edit deliverables covering all phases of research for submission to regulatory agencies.

    A key task of the Medical Writer is to be sure that all deliverables are in accordance with regulations, standards, and guidelines. The regulatory documents the team prepares must meet ICH, GLPs, and GCPs guidelines, a writing style guide, and often a company or client template.

    This combined with comprehensive literature searches to enhance and provide background are delivered with all RareMoon's deliverables.

    We write, review, and QC.

  • Investigator's Brochures
  • Document remediation
  • Nonclinical study reports
  • Annual ODD Reports
  • Annual IND & CTA Reports
  • eCDT report preparation and management

  • Clinical Study Reports
  • Study protocols
  • Patient Profiles
  • Risk/benefit analysis
  • Integrated summaries from raw data

  • To accomplish the primary goal of communicating information in clear, concise and compliant writing, medical writers perform many tasks.

    eCTD Submissions & Publishing

    RareMoon is well equipped with the expertise to create any XML file for submission to FDA, EMA and other regulatory authorities.

    Of note, the FDA has officially transitioned to XML based files for specific information including INDs & IND Amendments. The EMA is also implementing and improving ways to apply for designations, and interact with the various committees within the Agency.

  • eCTD submission publishing
  • Electronic report-level publishing
  • SPL, ACA's, FAERS and more
  • Paper to eCTD conversion
  • Submission review/viewing
  • Electronic submission to EMA
  • Submission to most Authorities outside the USA
  • Lifecycle Maintenance
  • Scanning (creation of electronic documents from paper)
  • Regulatory consulting and operations
  • Ops
  • Tasks related to eCTD and Lifecycle management
  • Critical input on document structure & granularity
  • Interpretation of regulatory guidelines (US and non US)