Regulatory Affairs – Medical Writing

  • CTD for EMA and US FDA submissions
    • m2.5 Clinical Overview
    • m2.4 Non Clinical Overview
    • m5, m2.7
    • Well Established Use
  • CDISC for US FDA submissions
  • Scientific & administrative support of regulatory queries
  • Medical Devices: Clinical Evaluation Report (MEDDEV 2.7/1 r4)
  • Expert reports

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