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What are businesses doing today for their FDA complaints submissions?

  • Outsourcing the process of building the solution and then maintain it internally with their IT staff (this is expensive)
  • Use the free WebTrader (this is manual and inefficient)
  • Outsource to expensive e-MDR services in case of high volumes (this is not ideal because you are reliant on a third party)

Pain points for the Regulatory Team

  • Lack of real-time visibility into the performance of e-MDR submissions
  • Risk of non-compliance (filing error or late submission)
  • e-MDR submission is a labor-intensive task for the regulatory team

The need: An efficient solution that reduces the need for more people, while also ensuring compliance. It must also be a solution that provides visibility to the quality team.

Pain points for the IT Team

  • Internal team might not have the expertise to develop a B2B solution
  • High level of support needed for the internal system
  • Out-of-the-box solutions might be too expensive

The need: A simple, cloud-based solution that reduces IT costs and the need for resources.

ComplianceQuest ensures that your e-MDR filing is always streamlined with no hassles. Download this whitepaper to understand how CQ’s e-MDR gateway can be the perfect solution to truly automate the process of high-volume complaints (eMDRs) to the FDA.

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