Medical and Regulatory Writing

RPI provides technical and medical writing and editing services for regulatory submissions in eCTD format. RPI’s Document Preparation Services include:

  • Regulatory / Health Authority Submission Documents for FDA and EMA
  • Regulatory Review – consistency of message, regulatory commitments
  • Clinical Documents – support for labeling
  • Document QC – data integrity

Examples of Regulatory Document Services

  • IND, NDA and MAA Modules (2.4, 2.5, 2.6, 2.7)
  • Investigator’s Brochures
  • Pre-INDs
  • DSURs
  • Regulatory Reponses
  • Pediatric Plans
  • ISS/ISEs
  • Briefing Books
  • Lay Summaries (EU)
  • Health Authority Meeting Materials

Examples of Clinical Document Services

  • Protocols
  • Protocol Amendments
  • Clinical Study Reports
  • Annual Reports
  • Narratives
  • Executive Summaries

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