EMA PLM Portal & IRIS integration.
The PLM (Product Lifecycle Management) Portal is the EMA's submission and management surface for ePI. Alnexia prepares, validates and submits ePI bundles, and integrates the workflow with IRIS eSubmission and your existing RIM.
What we deliver
Submission preparation
Bundle packaging, metadata, cover letter and procedural references.
Validator gate
Zero-error validator run before anything leaves the gateway.
PLM Portal hand-off
Direct upload via the Portal, with receipts archived in your evidence pack.
IRIS eSubmission alignment
Co-ordinated with the IRIS procedure for CAPs.
Lifecycle events
Variation, renewal, transfer and withdrawal updates carried through to the ePI.
Audit trail
Every submission tied to a CCDS change request and LRB decision.
Hypercare support
During the EMA voluntary phases we sit alongside your team — submission-by-submission — until your internal operations stabilise on PLM Portal cadence. We then transition to a lighter-touch managed-service model.
Artefacts you receive
- PLM Portal submission package
- Validator evidence
- Submission receipts
- Lifecycle event tracker
- Hypercare report
Sourced from regulators and industry leaders
- EMA — PLM Portal — European Medicines Agency
- EMA — IRIS — European Medicines Agency
Ready to scope this work?
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