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. EMC and partners offer Regulatory Submissions Management solutions to allow organizations to create and manage regulated content in EMC Documentum Compliance Manager.
You can then assemble and publish submissions in the electronic Common Technical Document (eCTD) format required or preferred by regulatory agencies worldwide. Integration between Documentum and regulatory publishing systems ensures that documents authored throughout the product life cycle can be assembled in the submissions, preserving a full audit trail.
Key Benefits
-
Preconfigured templates — Easily deploy with preclinical and clinical as well as chemistry, manufacturing, and controls (CMC) and regulatory content types in EMC Documentum Compliance Manager.
-
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 Documentum Compliance Manager — Maintain regulatory compliance and control for content included in submissions.
1-866-438-3622
