Key Features/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

Background

Electronic submission is becoming the expected norm for regulatory authorities around the world. Used by more than 20 companies, our Regulatory Submissions Tracking solution leverages on our E2B data exchange system, agXchange ESM, to provide a backbone for the electronic exchange of regulatory data. RSM manages and tracks the electronic distribution of regulatory submissions and receipts (MDN, ACK) in order to meet complex and often differing regional regulatory requirements.

xEVMPD

Regulatory Submissions Tracking is integrated with LifeSphere™ RIMS to support direct xEVMPD submissions but can easily integrate with home-grown or 3rd-party RIMS databases, even if they are not fully compliant with the xEVMPD standard.

UDI

The FDA deadlines for compliance with the unique identification and detailed information submission standards across different classes of medical devices started in 2014, with full compliance required by 2020. Maintenance processes are expected to run thereafter. RSM is fully compliant with UDI requirements.

eCTD

ArisGlobal's Regulatory Submissions Tracking can be utilized for eCTD submission.

IDMP HL7

Similarly, this technology will be embedded into our LifeSphere IDMP product, and is compatible with the HL7 messaging standard of ISO-IDMP.

regulatory submissions management system