Medical Writing

We have a strong expertise in the preparation of regulatory and medico-marketing documents.

Regulatory Documents

  • Clinical trial reports, Phase I-IV (ICH 3 or company specific SOPs)
  • CTD: Clinical and non-clinical summaries, clinical overviews
  • Observational and epidemiological study reports
  • Patient survey reports
  • Periodic Safety Update Reports (PSUR)

Medical Communication

  • Publication strategy
  • Preparation and submission of manuscripts for publication
  • Conference reports
  • Medico-marketing brochures
  • Specific marketing documentation