Active Dossier Feature Brief

Increase document visibility throughout the RIM lifecycle

Active Dossier is a list of a sponsor’s current and submitted documents across all products and markets. The Veeva RIM platform automates the generation and calculation of dossier records based on related submission data. Active Dossier then organizes linked documents into a multi-market document view based on data from the submissions process. This provides comprehensive oversight of the entire lifecycle of dossiers for regulatory authors, stakeholders, and managers in the end-to-end platform.

Business Benefits

• Unification:
  • Unify pre-approvals and standard disclosures into a single view
  • Provide more document context by connecting and aggregating data from different submissions
  • Facilitate external processes like batch disposition and clinical trial management from a single source of truth
• Speed and Accuracy:
  • Expedite identification of documents that require updates
  • Automate eCTD ingestion from Submissions Archive to easily establish initial baseline for new users
  • Ensure accuracy by generating Global Content Plan from Active Dossier

Features

View documents in multiple markets

• View the current, submitted, and superseded documents side-by-side by country in a single view.

• Filter and save dossier views based on product family, market, or region for quick access to relevant documents in a dossier.

Link to related documents and data

• Reference additional information on each document in the dossier, including the source document, submitted document, and translated document.

• Establish traceability by linking documents to related regulatory records, such as applications and submissions.

Integrate with other submission activities

• Automate generation of the dossier based on the existing regulatory submission process within the Veeva RIM platform.

• Maintain a calculated dossier lifecycle status based on the existing regulatory submission process in Veeva RIM.

Learn more about how Veeva Submissions can streamline your global regulatory submission process.