Create submission-ready content without knowing all the rules

IQVIA's submission document management system, Wingspan eREG, streamlines production of submission-ready documents so your team can focus on document content, not eCTD submission rules.

eREG helps all parts of your organization collaborate to produce the granular global content needed for submissions. Our solution supports submissions in dozens of countries and regions. 

  • Streamline document creation and filing with automatically populated metadata that helps you create submission ready documents in just a few clicks, including PDFs compliant with all health authority regulations. File documents in a CTD compliant structure.
  • Help your product teams initiate and manage workflows to capture 21 CFR Part 11 compliant electronic signatures.
  • Empower publishing teams to quickly and easily locate documents for submission, using metadata such as CTD section, file tag, or study characteristics.

Reach out today to set up an eREG demo. 

Defining compliance

Title 21 CFR Part 11 outlines the criteria under which electronic records and electronic signatures are considered by the US FDA to be trustworthy, reliable, and equivalent to paper records. Without this compliance, electronic submission is not permitted.