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.
- 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.
- 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.