Solution: enaio® for regulatory affairs

Drug Approval with enaio®

Regulatory affairs meet the digital age

The approval of drugs and medical products involves handling a large amount of documents. In recent years, manual document generation has largely given way to electronic processes. It is becoming increasingly common to submit information to authorities in PDF format.

The introduction of standards (eCTD, Nees, STED) has made documents smaller, but this has led to a considerable increase in the number of documents used. As a result, the administration of documents has become much more complex. File systems on file servers are no longer adequate as they do not meet the requirements of the authorities and standards.

There are many tasks that must be carried out to achieve modern and compliant document lifecycle management, including deadline management of all regulatory activities, the release and revision of approval documents, dossier management, the administration of associated documents, and the maintenance of a dossier record. enaio® provides the right tools for all of these tasks.

  • Dossier: structure templates for creating dossiers
  • Documents: Word templates for document creation, review, and release processes
  • Document record: filing of correspondence for each document and administration of all documents and files relevant for approval
  • Regulatory activities: monitoring of periodic tasks
  • Deadline management: follow-up, e-mail reminder, and subscription function

Administration and filing

Benefit from central access to your documents – anytime, from any location.

Planning and tracking

Maintain a comprehensive overview of your regulatory activities.

Creation and provision

Ready-made templates support the creation of consistent documents.

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

Our reference: 

Digital regulatory affairs at Allergopharma GmbH & Co. KG

To the reference

  • “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.”

    Wolfgang Gleiniger
    Head of IT Applications
    Allergopharma GmbH & Co. KG