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.