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agXchange RSM™

End to end submission management

agXchange RSM™

End to end submission management

Key Benefits


  • Closely integrates affiliates into a paperless safety submission process
  • Facilitates local reporting compliance as affiliates make decisions and add local content
  • Enhances efficiencies in reporting and tracking using appropriate media
  • Supports submission of eCTD and other regulatory documents
  • Supports the submission of product data in accordance with xEVMPD and UDI

agXchange RSM™– Supporting xEVMPD Submissions and Beyond

Regulatory Submissions Tracking is a flexible tracking solution that manages and tracks the electronic distribution of regulatory submissions and receipts to meet complex and often differing regional regulatory requirements. The regulatory compliance software solution leverages the E2B data exchange system, agXchange ESM™, to provide a backbone for the electronic exchange of regulatory data.

Built on open architecture, Regulatory Submissions Tracking is an xEVMPD electronic submission solution that is integrated with LifeSphere® RIMS to support direct EMA xEVMPD submissions but can easily integrate with home-grown or third-party RIMS databases. Regulatory Submission Tracking is also a medical device tracking solution and is fully compliant with UDI requirements.

In addition, Regulatory Submission Tracking can be deployed as an eCTD submissions software solution, and supports other regulatory documents. Regulatory Submissions Tracking is also compatible with the HL7 messaging standard of ISO-IDMP.

agXchange RSM™ – Supporting xEVMPD Submissions and Beyond

Regulatory Submissions Tracking is a flexible tracking solution that manages and tracks the electronic distribution of regulatory submissions and receipts to meet complex and often differing regional regulatory requirements. The regulatory compliance software solution leverages the E2B data exchange system, agXchange ESM™, to provide a backbone for the electronic exchange of regulatory data.

Built on open architecture, Regulatory Submissions Tracking is an xEVMPD electronic submission solution that is integrated with LifeSphere® RIMS to support direct EMA xEVMPD submissions but can easily integrate with home-grown or third-party RIMS databases. Regulatory Submission Tracking is also a medical device tracking solution and is fully compliant with UDI requirements.

In addition, Regulatory Submission Tracking can be deployed as an eCTD submissions software solution, and supports other regulatory documents. Regulatory Submissions Tracking is also compatible with the HL7 messaging standard of ISO-IDMP.

Key Benefits
  • Supports the submission of product data in accordance with xEVMPD and UDI
  • Out-of-box integration with LifeSphere™ RIMS
  • Integrates with any source product database
  • Supports submission of eCTD and other regulatory documents

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