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Regulatory Medical Writing

Over the years I have gained experience in a the planning, writing and reviewing of many documents. Some examples are outlined below:

  • Co-ordinating and writing phase I‑IV clinical study reports
  • Planning and writing of summary documents including the clinical overview and clinical summaries
  • Planning and writing other regulatory specific documents including investigator brochures
  • Patient narratives
  • Written responses to regulatory authorities in support of licence conditions and renewals
  • Other regulatory medical writing