Clinical and Regulatory Medical Writing

Our writing skills and industry expertise ensure Acadustri can provide the support and guidance needed to prepare the following clinical and regulatory documents:

  • Clinical Study Reports for phase I-IV trials to ICH guidelines
  • Investigator’s Brochures
  • Study Protocols & Protocol Amendments
  • INDs & NDAs in CTD formats
  • ‘Response to Questions’ Documents
  • Responses to EMA Day 120 & Day 180 Questions
  • Briefing Books for EMA & FDA Scientific Advice
  • Applications for Orphan Drug Designation
  • Investigational Medicinal Product Dossiers
  • Literature searches/reviews

Contact us to discuss your project needs.

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