Related Information

Regulatory Submissions Management

Create, assemble, review, publish, and archive electronic submissions while ensuring compliance.
Regulatory Submissions Management solutions enable regulated content management while meeting compliance requirements. We offer Regulatory Submissions Management solutions to allow organizations to create and manage regulated content..

You can then assemble and publish submissions in the electronic Common Technical Document (eCTD) format required or preferred by regulatory agencies worldwide. Integration between a document management system and regulatory publishing systems ensures that documents authored throughout the product life cycle can be assembled in the submissions, preserving a full audit trail.

Business Advantages

• Preconfigured templates — Easily deploy with preclinical and clinical as well as chemistry, manufacturing, and controls (CMC) and regulatory content types.
  
  
• eCTD creation and assembly wizards — Manage the complete electronic common technical document (eCTD) submission lifecycle from a web-based interface.
  
  
• Cross-document hyperlink management — Create cross-document links as submissions are being assembled to ensure that links will never break.
  
  
• Global agency submissions — Reuse all or part of a U.S. submission for submissions to the E.U. or Japan in a few easy steps.
  
  
• Integration with Document Management System — Maintain regulatory compliance and control for content included in submissions.