
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.