Vault Registrations provides a single global application for planning, tracking and reporting on product registrations and health authority correspondence and commitments. The improved visibility and data quality will streamline registration management and speed responses to health authorities.
- Improved data quality: Streamline registration management by reducing data duplicates and discrepancies.
- Global visibility: Stay informed with complete visibility into the marketing status of your global product portfolio.
- Faster responses to health authorities: Track queries and commitments to stay ahead of response deadlines.
- Unifying regulatory: Streamline end-to-end submission development, gaining visibility and efficiency with the unified Vault RIM Suite.
Find Out How
MANAGE PRODUCT REGISTRATIONS GLOBALLYManage all product registration details including formulation specifics, modes of delivery and dosage forms, indications, manufacturing details, and packaging.
EXECUTE IMPACT ANALYSESGenerate reports to identify which registrations are impacted by any type of change – packaging, manufacturer, API supplier, inactive ingredient.
MANAGE REGULATORY EVENTSBuild a plan for and manage your response to regulatory events by creating the associated activities and assigning responsible parties.
TRACK SUBMISSIONSPlan, manage, and track the status of submissions and related activities. This includes the data related to initial clinical trial submissions (CTAs, INDs) and initial marketing submissions (NDAs, MAAs).
MANAGE INTERACTIONS AND COMMITMENTSRetain and classify all correspondence with health authorities. Create commitment records with related tasks and report on progress against outstanding commitments and deliverables.
DASHBOARDS AND REPORTSCreate easy, self-serve reports showing information by any combination of attributes including: product, application, region, manufacturer, and more.
IDMP and xEVMPD SUPPORT (Future release)Provide an authoritative source for medicinal product information across the organization. Leverage system workflows to enrich, review and verify data. Generate and submit xEVMPD and IDMP messages directly to the gateway and manage acknowledgements and IDMP IDs. Learn about Veeva’s approach to IDMP, watch video.
xEVMPD support planned for early 2019. IDMP support pending final implementation guides.