Sofus is ready to assist your company with all kinds of projects within applications and renewals, literature reviews and format updates for the different regulatory procedures within the EU and the Nordic area.

We frequently handle projects involving quality aspects of the dossier (Module 3), where our services include review/update of old documentation including contacts with manufacturers.

Some of the services we provide within the service area dossier management are:

• Checking and preparing the application for all EU submission procedures
• Management of the submission life-cycle during the application procedures and during the post-marketing phase
• Preparation and compilation of electronic dossiers for submissions according to the regulatory requirements (eCTD and NeeS)
• Preparation of duplicates/line extensions
• Perform due diligence of a product’s regulatory status