Four parallel service lines. One labeling partner.
Alnexia offers Regulatory Labeling, ePI, FDA SPL and Artwork Management as independent practices. Engage any one of them on its own, or combine them into a single end-to-end label lifecycle — your choice, your scope.
Independent services — not a single ePI funnel.
Each pillar is its own delivery team, SOPs and tooling. ePI is one of them, not the umbrella.
ePI (EMA, HL7 FHIR)
Electronic Product Information aligned to the EMA EU ePI Common Standard and hl7.eu.fhir.epil IG. Authoring, FHIR conversion, validation and PLM Portal submission.
- ePI authoring & SPOR mapping
- FHIR XML/JSON conversion
- PLM Portal & IRIS submission
- Fidelity scoring & validator evidence
Pick one practice, or combine them.
Single practice
Engage Regulatory, ePI, SPL or Artwork as a standalone scope — staff augmentation or fixed deliverable.
Linked practices
Run two or three together (e.g. Regulatory + Artwork, or ePI + SPL) with shared change-control across markets.
Full label lifecycle
All four practices under one Alnexia program — CCDS to artwork to ePI to SPL, governed end-to-end.