eCentral

Provides the total solution for Regulatory Content Management and Submission Publishing that today’s complex regulatory environment demands. Complete Interoperability. Integrates with your Document and Content Management Systems including Documentum, Livelink, or Qumas.

All-inclusive
All regions supported for worldwide applications including US, EU, Japan, Canada
All submission types supported such as eCTD, eIND, eNDA, eBLA, MAA, etc.

All-around
PDF Toolkit included for the modification, file management, and navigation of your PDF documents
SPLEditor included for the creation and management of your labeling content in the SPL format
Additional eCTD publishing applications for submission Lifecycle management, StudyTagging File generation, Submission Validation, eSubmission Comparison, TOC Creation, eSubmission Printing, and eCTD Review

Role-Orientated Security
eComposer provides expanded user and group configuration to reflect unique capabilities, responsibilities, and job functions.