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Product Trust · Digital Labelling

Regulated product information, live behind every pack.

Replace paper leaflets with governed, standards-based digital product information — verified, versioned, multilingual, and ready for inspection.

Built on GS1 Digital Link. Governed by the PharmaLedger Association. Live in production.

PharmaLedger helps pharmaceutical manufacturers replace paper product information with governed, regulator-ready digital infrastructure. It starts with ePI. It expands into supply-chain intelligence and patient engagement on the same product-trust spine — neutral, standards-based, live, and procurement-ready.

Since 2022In production, live in market
€22MEU IMI research heritage · 2019–2022
Not-for-profitSwiss association — can't be bought or flipped
Industry boardGoverned by global manufacturers
GS1 · EMA ePIStandards-native by design
Founding members & partners
GSKMSDTakedaAbbVieModernaElanco
The consortium that governs the platform — global manufacturers, technology providers and patient organizations. See the production evidence on the Proof page. See production evidence
01 · The problem

The most regulated industry on earth ships its most critical information on paper.

Folded into every carton is a document that cannot be updated, cannot be verified, and is out of date the day the regulator approves a change. Your batch records went digital. Your supply chain went digital. The one artefact that actually reaches the patient did not.

~26 wks
for a paper labelling change to reach the patient's hands
€500K
per change, per market — artwork, reprint, repackaging, write-off
0
ways to correct what a pack says once it leaves the line
Benchmark ranges from industry labelling-change cost models — assumptions and scope below.
What is behind these numbers?

Based on the industry labelling-change cost model. Assumptions: artwork revision, QA review and approval loops, print, repackaging, obsolete-stock write-off, and market-specific variation handling. Figures are illustrative ranges for a single change in a single market — not upper bounds. The full calculator, adjustable to your portfolio, is part of the briefing.

Download the executive brief (includes the model summary)
Two clocks are already running

Paper fails you twice: in euros, and in hours.

The cost of a single label change

Every paper change has a price tag.

One safety wording update, one market. Follow it through the paper chain — then through the platform.

Now multiply the left side by every SKU, every market, every year.

02 · The platform

Stop managing documents. Start operating truth.

The Product Trust Platform is the operating layer for product information: one governed source of truth, verified at every step, delivered to every market, every channel and every patient — the moment it changes.

Product Trust Platform

One neutral platform. Three products.

Hosted by the PharmaLedger Association — governed by its members, not owned by any one of them.

03 · The products

Start with the funded problem. Expand on the same spine.

01

AstraLabel Start here · System of record

The system of record for electronic product information (ePI) — structured, versioned, live in every market at once, with update cycles cut from weeks to days.

Explore AstraLabel on the platform
02

AstraTrace Expansion · Supply intelligence

A decision layer over the systems you already run — Daily Pulse, Historical Analytics, Year-on-Year and Shelf Life views that turn hindsight into foresight.

Explore AstraTrace on the platform
03

AstraEngage Expansion · Patient interface

The trusted interface between your product and the person taking it — 29 languages, text-to-speech, privacy by design: no personal data is captured on scan.

Explore AstraEngage on the platform
04 · For your role

One spine of truth. Three different pay-offs.

The person who owns the mandate isn't the only one who wins. Here's what comes back to each chair.

VP, Supply ChainStock · Shortages · Waste

You find out about shortages when the crisis call starts — and every label change ends as pallets of your stock in a shredder.

The manufacturer playbook Book the supply chain briefing
Head of Regulatory AffairsVariations · Compliance · Inspections

Every variation is a race between the approval letter and the stock already in the channel — and you carry the gap.

ePI readiness for 2027 Book the regulatory briefing
Head of Patient EngagementEnrolment · Adherence · Consent

Millions of packs reach patients you never meet — every one an impression you don't own and can't measure.

The patient-side view Book the engagement briefing
07 · Deployment & pricing

Transparent pricing. Keep your sovereignty.

Published pricing across the platform — deployment paths for digital product information, supply-chain intelligence tiers, and early-adopter access to the branded patient apps. Start where you are; nothing gets redesigned as you scale.

AstraLabel · digital product information (ePI)
COREShared SaaS
from CHF 2,250per leaflet · per year

Fully managed on shared infrastructure with minimal internal resources — the fastest way to be live and compliant.

  • Full service: conversion, upload, management
  • Turn-key validation package included
  • Ideal for pilots and focused portfolios
EDGEOn-premises
CHF 19,999per month

On-premises deployment with full control over infrastructure and data residency — sovereignty by design.

  • Full control of infrastructure and residency
  • Qualified deployment packages
  • Deep integration with e2e systems of record

Includes leaflet conversion, hosting, validation pack, and support. Custom integrations and market-specific services are scoped separately.

AstraTrace · supply-chain intelligence
STARTERShared SaaS
€499per month

Inventory observability for a focused product set — live in weeks, no infrastructure.

  • 25k events per month
  • 50 GTINs · 5 users
  • Core dashboards and alerts
ENTERPRISEDedicated instance
from €15,000per month

Unlimited scale on a dedicated instance, shaped to your network and governance.

  • Unlimited events and GTINs
  • Dedicated instance
  • Enterprise support and SLAs

Add-on modules — product verification, cold-chain intelligence, shortage intelligence, trading partners and more — from €18,000 per year; module pricing in the briefing.

AstraEngage · branded patient appsComing Q4 2026

The branded patient apps arrive with the medicine cabinet and adherence tracking. Early-adopter pricing for commitments before general release — the PLA-branded patient app remains included today.

BRANDEDYour app, our platform
€27,000per year · early adopter€36,000

Your brand in the app stores on the platform patients already trust.

  • MAH app-store presence, custom branding
  • Push notifications
  • Scan-to-leaflet and product lookup

Early-adopter pricing applies to commitments made before general release at end Q4 2026.

Every tier includes hosting, validation support, and the platform trust layer. Custom integrations, market-specific services, and migration support are scoped separately.

AstraEngage microsites, consent and programme capabilities are licensed as modular capabilities today — entry tiers that scale to enterprise, with bundle discounts for platform commitment. The PLA-branded patient app is included. Module pricing is shared in the briefing.

08 · For your buying committee

Everything internal diligence needs, one link each.

RegulatoryePI readiness, version control, inspection viewProduction evidence
QAValidation approach, SOPs, GxP postureTrust Center
IT / SecurityArchitecture, data residency, IAM, audit trailArchitecture reference
ProcurementPricing, deployment models, supplier qualificationDeployment & pricing
LegalGovernance, bylaws, privacyAssociation governance
05 · Why now

This isn't a trend to watch. It's a schedule to meet.

Japan has been fully digital since 2021. EMA rollout begins with vaccines in Q3 2026. The mandate map is filling in market by market — and the organisations moving now are positioning for controlled execution rather than emergency response.

06 · The association

Infrastructure this critical shouldn't belong to a vendor.

In regulated infrastructure, trust is earned through structure, not promises. The platform is hosted by a not-for-profit association and steered by the companies that run on it — that isn't positioning, it's the legal structure.

Neutral by structure

Not venture-backed, not for sale. The platform can't be bought, flipped or priced against its members.

Governed by peers

Direction is set by the industry that uses it. Your peers sit on the board — not a vendor's investors.

Standards-native

GS1 Digital Link, EMA ePI, FHIR. We implement the standards the industry already agreed on.

Built for scrutiny

Verified audit trails and qualified infrastructure — designed to be shown to a regulator, not explained to one afterwards.

Three stakeholder groups. One ecosystem.

PLA's network spans the full pharmaceutical value chain — from manufacturers and technology providers to patient associations and health authorities. Each group brings something the others cannot: scale, technical capability, regulatory authority, and patient voice.

Marketing Authorisation Holders

Pharmaceutical and animal health MAHs use AstraLabel and AstraTrace as commercial platform services. They also shape the platform roadmap through Committees and, at Patron level, through Board representation.

Current MAH members: GSK · MSD · Takeda · Moderna · Elanco

Technology Organisations

Technology members contribute to the open-source PTP codebase, integrate with the platform via API, and participate in technical standards-setting. PLA's technology committee sets the architecture direction for the platform's evolution.

Standards: GS1 · HL7 FHIR · Hyperledger · EPCIS 2.0

Patient Associations

Patient associations ensure that platform development remains patient-centric — not just technically compliant. Their participation in PLA governance anchors the mission in the outcomes that matter: patients receiving trustworthy, accessible medicine information.

Focus: accessibility · adherence · patient safety

Designed with the industry · founding research partners, EU IMI programme 2019–2022
AbbVieAstraZenecaBayerBoehringer IngelheimGSKJanssenMerck KGaANovartisNovo NordiskPfizerRocheUCB
A €22M, 29-partner research programme across 10 EU member states — requirements written by the companies that deploy it.
32+
members of the association
12
global pharma founders
46
countries assessed for compliance
29
languages live today
3+ yrs
in production since 2022
0
unplanned departures, 2025 replatform
Questions, answered

What buyers ask before the briefing.

01What is the Product Trust Platform?
The Product Trust Platform is the operating layer for pharmaceutical product information — one governed source of truth, verified at every step, delivered to every market and channel the moment it changes. Three products run on it: AstraLabel™ (digital labelling and ePI), AstraTrace™ (supply chain intelligence) and AstraEngage™ (governed patient engagement). It is hosted by the PharmaLedger Association, a Swiss not-for-profit.
02What is electronic product information (ePI)?
ePI is the structured, digital form of the product information that today ships as a paper leaflet. Because it is structured and governed rather than printed, it can be updated the day a change is approved, delivered in the patient's language through the GS1 Digital Link QR code on the pack, and audited end to end — the pack always resolves to the current version.
03Who already runs on the platform?
The platform has been in production since 2022 and is trusted by manufacturers including GSK, MSD, Takeda, AbbVie, Moderna and Elanco. It originated in a €22M EU IMI research programme (2019–2022) whose founding partners included twelve global pharmaceutical companies, and the association has grown to 32+ members.
04Why is a not-for-profit hosting critical infrastructure?
Because neutrality has to be structural, not contractual. The PharmaLedger Association is a Swiss not-for-profit steered by the companies that run on the platform: it cannot be bought, flipped or priced against its members, fees fund the work rather than investor returns, and direction is set by an industry board.
05Which regulatory deadlines make this urgent?
The mandate map is filling in market by market: Japan has been fully digital since 2021, EMA's ePI pilot completed in 2025 with rollout beginning Q3 2026, GS1's US Sunrise initiative makes 2D barcodes the retail point-of-sale standard in 2027 — directional for pharma packaging, and EU pharma reform is expected to write ePI into legislation in 2028. The Belgium–Luxembourg pilot has already served four million packs digitally, with 97% of hospital pharmacists reporting no issues. Connecting takes months — teams that start now meet every milestone.
06How is it priced?
Three deployment models for the digital product information service: CORE, fully managed shared SaaS from CHF 2,250 per leaflet per year; SOLO, a dedicated SaaS instance with complete data isolation at CHF 14,999 per month; and EDGE, on-premises deployment with full infrastructure and data-residency control at CHF 19,999 per month. Conversion, hosting, validation pack and support are included; custom integrations and market-specific services are scoped separately. AstraTrace is published from €499 per month, scaling to enterprise. The AstraEngage branded patient apps — medicine cabinet, reminders, adherence — arrive end Q4 2026 with early-adopter pricing for commitments before general release; the PLA-branded patient app is included today. Portfolio and bundle terms are covered in the briefing.
07What about patient privacy?
Privacy by design: no personal information is collected when a patient scans a pack. The scan reads the product identifier and returns the approved information — the system does not track who scanned, when, or where.
08How do we evaluate it?
Start with the two-page executive brief, then book a 45-minute platform briefing tailored to your portfolio and markets — including the full labelling-change cost model. Detailed production metrics are shared under NDA.
Next step

The switch to digital product information is happening on a schedule. Set yours.

Focus
Book a platform briefingDownload the executive brief
days to Sunrise 2027 — briefings run 45 minutes, tailored to your portfolio and markets. No demo theatre.