Available as modular booking for EUDAMED (UDI, Vigilance/MIR) and FDA (UDI/GUDID, eMDR) – depending on market and workflow. You upload your data via Excel template; the portal automatically checks completeness, plausibility, and format, reduces rejections, and accelerates submission. After that, M2M submission to the authority (where available) takes place – without manual portal steps. You can always see status per submission, receive feedback/error messages back in a structured way, and maintain a clean evidence/audit history as proof for RA/QM (including logs and exportable results).
The Global Submission Portal is a central platform for regulatory submissions that reduces the workload for teams in Regulatory Affairs and Quality Management: fewer manual portal steps, better data quality, and a clear overview of submission status.
The benefits are intentionally phrased close to RA/QM needs – operational, auditable, traceable.
Modular by workflows (EUDAMED / FDA) – with included data volume. Additional volume and enterprise setup on request.
Ideal to start with one target workflow (EU or US).
For parallel workstreams and growing portfolios.
For global organizations, multiple sites/SRNs and high volume.
You can start with one module today and expand later.
Term: monthly or yearly.
UDI submission including validation and status overview.
Incident reporting / MIR workflows with structured processing.
eMDR submission with validation, M2M transfer, and feedback.
UDI-related US workflows with a consistent Excel pattern.
We are happy to present references and case studies in a demo call (after approval).
If you currently have a comparable starting point (e.g., high UDI volume, multiple markets, M2M integration), please share the approximate data volume and target modules – then we will show you the most relevant reference.
Please select at least one module – we will get back to you with a suitable proposal and the next steps.