Medical Writing



EuDRAcon can meet your needs by writing, assembling and preparing the following documentation:

  • Module 1.6 – Environmental risk assessment
  • Module 1.8 – Information relating to Pharmacovigilance
  • Module 2.4-2.7 – Non-clinical Overview, Clinical Overview, Non-Clinical Summary, Clinical Summary
  • Module 3 – Quality
  • Summary of product characteristics (SPC)
  • Patient information leaflet (PIL)
  • Product labelling
  • European Drug master file
  • Expert reports for toxicological, clinical and environmental compatibility
  • Quality overall summary

The listed services are only a part of our medical writing portfolio. We have extensive experience across a wide range of medical writing requirements. To discuss the documentation you need to be prepared, contact our member companies.