Dossier management pharma

The regulatory requirements for the documentation of a pharmaceutical drug have steadily increased due to constant progress and new findings. As a result of this, the amount of data and the complexity of the registration of documents also increase, which places even higher demands on the handling of the included documentation.

Advantum Dossier management pharma is an efficient solution for creating, maintaining and archiving documentation in a CTD (Common Technical Document) structure that is automatically generated for products.

Advantum Dossier management pharma helps create, maintain and archive documentation for products in a CTD structure where they are handled with variations and sequences as well to easily follow what have been sent to authorities and also store the correspondence. The system of course automatically keep track on the "Current file", i.e. which documents are approved by authorities. The structured information and files can easily be exported as a basis for an eCTD (electronic Common Technical Document).

Examples of functions in Advantum Dossier management pharma:

• Create and manage products
• Manage CTD structure, variations and sequences for different countries
• Structure documentation according to CTD structure
• Create and manage documents
• Template management
• Version management
• Electronic signature
• Create and manage and sign with role
• Standardized processes
• Find information based on different perspectives and search functions
• Management of access rights via groups and roles
• Audit trail
• Prepared import for documents