ReALM® Registrations allows for management of product registration information for various markets, specifically around any pre-registration and site registration activities. The Registrations module comes with web services, such as document management and submission publishing, that allow integration to enterprise and cloud applications.

Features:

  • IDMP-ready product master definition and inclusion of controlled vocabularies for most data elements.
  • Ability to manage product registration information and approval letters and approved labels. 
  • Ability to search for various characteristics of product registrations. 
  • Ability to manage life cycle stages including variations, amendments, etc. 
  • Dashboard of product registrations by country, product and status, etc.
  • Integration with upstream document management and submission publishing applications.
  • Integrate ReALM® Interactions module to track health authority interactions (correspondences, requests, and commitments) by product and country.

Benefits:

  • Distribute ownership of product registrations and approvals at the country, regional, and headquarters levels.
  • Provide visibility to up to date product life cycle information and approval status.

Learn more about other ReALM® modules here.

Product Demo

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