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PharmaLedger Association
Executive brief · For directors and above

Paper product information now has an expiry date.

The case for moving product information, supply visibility and patient engagement onto one verified, member-governed platform — before the regulatory window closes.

The problem

The most regulated industry on earth still ships its most critical information on paper — a document that cannot be updated, cannot be verified, and is out of date the day the regulator approves a change.

~26 wksfor a paper labelling change to reach the patient's hands
€500Kper change, per market — artwork, reprint, repackaging, write-off*
0ways to correct what a pack says once it leaves the line

The platform

The Product Trust Platform is the operating layer for product information: one governed source of truth, verified at every step, live behind every QR code in every market the moment a change is approved. Three products run on it:

AstraLabelSystem of record

Structured ePI authoring, version control and approval workflows, with a blockchain-verified audit trail and same-day propagation to every market and language.

AstraTraceSupply intelligence

Inventory observability across trading partners, early shortage and disruption signals, and regulator-ready reporting from live operational data.

AstraEngagePatient interface

The current leaflet in the patient's language from one scan, governed microsites and programmes, with consent captured and auditable on every interaction.

What changes for your organisation

Supply chain

Shortage signals days early, stock visibility across partners, label-change write-offs eliminated.

Regulatory affairs

One approved truth in every market; safety variations live at points of care the day they're approved; the audit trail already open at inspection.

Patient engagement

Every scan becomes an owned, consented touchpoint with adherence signals you can put in a quarterly review.

Finance & ESG

The industry business-case model projects >£5M operating-cost reduction within five years and a 0.1% revenue uplift for a top-47-markets portfolio, with Net Zero packaging targets enabled for 75%+ of packs by 2030.**

Deployment & pricing: digital product information from CHF 2,250 per leaflet per year (CORE, shared SaaS) · CHF 14,999 per month (SOLO, dedicated SaaS) · CHF 19,999 per month (EDGE, on-premises). Conversion, hosting, validation pack and support included; portfolio terms covered in the briefing.

Why now

  • 2025EMA ePI pilot completes — first electronic leaflets live; Switzerland permits paperless for HCP-administered products (Dec)
  • 2026National e-leaflet programmes expand across marketsYou are here
  • 2027GS1 Sunrise — 2D barcodes scanned at the point of sale
  • 2028EU pharma reform — ePI written into legislation
  • 2030Digital becomes the default; paper the fallback

Connecting takes months, not weeks. Teams that start now meet every milestone on this line.

Why the Association

The platform is hosted by the PharmaLedger Association, a Swiss not-for-profit steered by the companies that run on it — grown from 29 founding research partners to 32+ members today. Neutral by legal structure: not venture-backed, not for sale, and incapable of pricing the network against its members. Standards-native (GS1 Digital Link, EMA ePI, FHIR) with verified audit trails and qualified infrastructure designed for regulatory scrutiny. The 2025 replatform completed with zero unplanned customer departures and zero-downtime migration.

Founding research partners (EU IMI programme, 2019–2022): AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, GSK, Janssen, Merck KGaA, Novartis, Novo Nordisk, Pfizer, Roche, UCB — 29 partners across 10 EU member states, with EU Commission and EFPIA endorsement through Horizon 2020.

In production since 2022€22M EU IMI research heritage29 partners · 10 EU member states32+ members todaySwiss not-for-profit associationGS1 · EMA ePI standards-native
Next step: a 45-minute platform briefingTailored to your portfolio and markets — the full labelling-change cost model included. No demo theatre.
Book a briefing

* Benchmark ranges from industry labelling-change cost models; the full model is shared in the briefing.

** Indicative modelling from the industry business-case framework (2022); validated against your portfolio in the briefing. Detailed production metrics — MAHs live, markets served, patient interactions — are shared under NDA.