Dossier Management

Sofus is ready to assist your company with all kinds of projects within applications and renewals, literature reviews and format updates. We can help you to check and prepare application dossiers for different regulatory procedures within the EU and the Nordic area and we can prepare and manage dossiers in the eCTD-format.

Sofus has renowned software for preparing and managing dossiers in the eCTDformat. Sofus’ eCTD-manager is compatible with all available eCTD-formats (xml).

Some of the services we provide within dossier management are:

• Checking and preparing the application dossier for all submission procedures within the EU
• Perform due diligence of a product’s regulatory status
• Preparation and compilation of electronic dossiers for submissions according to the regulatory requirements (eCTD and NEES)
• Management of submission life-cycles during the application procedures and during the post-marketing phase
• Literature searches and/or reviewing of texts
• Bookmarking and hyperlinking of PDF documents
• Formatting of Word documents (e.g. final formatting of Module 2 and 3 documents)

To read the full brochure, please click here.