Product Information Management

ProductExpert™ addresses planning and management of medicinal product data submissions throughout the submission lifecycle, post-submission, and post-approval according to the IDMP target operating model.


ProductExpert™ Features

  • Tracking medicinal product registrations, content and other meta-information
  • IDMP data granularity and support for the target operating model
  • Support for internally and externally defined controlled vocabularies with RMS interoperability
  • Master data life cycle management supporting product information reuse
  • Integration with data extraction tools to support data enrichment and quality control
  • Rich data and business rule validations
  • Advanced automation of processes as part of the end-to-end RIM
  • Embedded XEVPRM creation and EMA gateway communication including acknowledgement processing
  • Embedded FHIR creation and EMA PMS data submission including status tracking
  • History and record tracking of medicinal product information
  • Archiving of XEVPRM and FHIR messages and acknowledgments
  • Interactive dashboards for actionable product information overview

Discover our Life Sciences solutions

Connect with us today!