Tackling the Challenges of CMC Dossiers

The creation of scientific and quality documents is often complex, cumbersome and time consuming. Manual data entries must to be re-verified. Multiple experts across the organizations have to collaborate to compile large amounts of data to create documents of hundreds of pages like for CMC dossiers. And furthermore, document creation is not a one time off. It is an ongoing process. Some of them are produced over ten to fifteen years of product development time and still updated.

Are you still creating your CMC dossiers via copy-and-paste and reverifying every single data point?  Then your processes might be error-prone, leading to inconsistencies, lacking traceability and endanger your IP. BIOVIA Structured Document Authoring is a radically new way to create documents. It is data-centric moving away from static documents. It is automated versus manually searching and entering data. Which also make data reverification obsolete.

BIOVIA Structured Document Authoring > Dassault Systemes


  • Author and share documents
  • Standardize document content, format and layout
  • Automatically update document content
  • Collaborate securely and controlled
  • Get oversight of updated and used content 


  • Reduce time creating dossiers by 80%
  • Reduce costs by $2M+ per dossier
  • Produce accurate reports with current and up-to-date data
  • Save 30 – 70% of time omitting data reverification
  • Maximize transparency and traceability 
  • Protect your IP
  • Speed time to market
Structured Document Authoring > Dassault Systemes

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