Preparation, review or assistance with the following:

Regulatory and Clinical Writing

  • Investigators’ Brochures
  • Clinical Study Protocols & Amendments
  • Clinical Study Reports
  • Development Safety Update Reports
  • Periodic Safety Update Reports
  • Clinical & nonclinical sections CTD Module 2
  • Paediatric Investigation Plans/iPSPs
  • Clinical Evaluation Plans/Reports
  • Clinical Investigation Plans and Reports
  • Summary of Safety and Clinical Performance (SSCPs)
  • Reports of Prior Investigations
  • PMCF Plans and Reports
  • Patient Safety Narratives

Clinical Development

  • Clinical Development Plan
  • Target Product Profile
  • Briefing Books for scientific advice

Scientific Communication

  • Publications
  • Posting of clinical trial results on EudraCT/ ClinicalTrials.gov (at Sponsor’s request)
  • Promotional material
  • Posters, Abstracts, Slides