Solution: enaio® for regulatory affairs
Drug Approval with enaio®
Regulatory affairs meet the digital age
Easy Data Handling with Templates for Documents and Dossiers
Connect regulatory affairs with the ECM
Efficiently manage all drug approval documents with our best-practice solution for regulatory affairs. Every document and file needed in connection with regulatory requirements and submissions can be managed in a transparent manner with our solution.
It supports existing filing structures as well as new, supplementary ones, while structure templates allow you to create dossiers (eCTD, Nees, STED) with ease.
- Comprehensive deadline management
- Planning and tracking of regulatory activities
- Complete document and dossier record
- Full lifecycle of documents and dossiers
- Management of Word templates that facilitate the creation of consistent documents
- Assign any attributes to each document and file
- Interface to EXTEDO eCTDmanager and Lorenz DocuBridge offers logged release processes for approval documents (draft, review, approved, invalid) and makes them available to the dossier management tool
“The introduction of an ECM system was intended to ensure the efficient production of patient-specific drugs and to reduce the time and effort required for documentation by means of electronic archiving.”