# PharmaLedger

> PharmaLedger is the verified-truth layer for pharmaceutical supply chains, electronic product information, and clinical research. A neutral, member-governed nonprofit (PharmaLedger Association, Zurich) operating the Product Trust Platform: one verified product record that manufacturers, regulators, and patients can all trust.

Key facts:
- Origin: EU Innovation in Medicine Initiative (IMI) PharmaLedger project, launched 2020, Novartis-led, €22.1M EU + EFPIA funding, 29 founding partners (12 global pharma).
- Members include GSK, MSD, AbbVie, Takeda, Moderna, and Elanco.
- In production: the ePI by PharmaLedger app is live in 46 countries, delivering approved electronic product information in 29 languages.
- Standards: GS1 Digital Link, EU Digital Product Passport (DPP), EPCIS 2.0 — connected, not replaced.
- Architecture: tamper-evident, hash-chained audit trail; GxP-aware; GDPR-compliant aggregate-only analytics; managed SaaS or self-hosted.

## Products

- [Platform overview](https://pharmaledger.org/platform): The Product Trust Platform — one verified layer, three production-grade solutions.
- AstraLabel: digital labelling and electronic product information (ePI).
- AstraTrace: end-to-end pharmaceutical supply-chain intelligence and traceability, including cold chain.
- AstraEngage: patient and healthcare-professional engagement.

## Solutions by audience

- [For pharmaceutical manufacturers](https://pharmaledger.org/solutions/pharmaceutical-manufacturers): One verified record from approval to the patient.
- [For regulators & health authorities](https://pharmaledger.org/solutions/regulators): The same verified record the manufacturer sees.
- [For hospital & retail pharmacy](https://pharmaledger.org/solutions/hospital-pharmacy): Scan the pack. Trust the answer.
- [For patient organizations](https://pharmaledger.org/solutions/patient-organizations): Information patients can act on — and trust.

## Standards explained

- [GS1 Digital Link](https://pharmaledger.org/standards/gs1-digital-link): The GS1 standard that turns the barcode on a medicine pack into a web address — one 2D DataMatrix that serves regulators, supply chains, and patients at the same time.
- [EPCIS 2.0](https://pharmaledger.org/standards/epcis-2-0): The GS1 standard for sharing what happened to a product — what, when, where, why — as machine-readable events across every hand it passes through.
- [EU Digital Product Passport](https://pharmaledger.org/standards/eu-digital-product-passport): The EU's coming requirement for a machine-readable passport of product data — identity, composition, compliance — resolvable from the product itself.
- [ePI on HL7 FHIR](https://pharmaledger.org/standards/epi-fhir): The HL7 standard that turns the paper package leaflet into structured, interoperable healthcare data — the format regulators are converging on for ePI.

## Regulatory intelligence

Curated, primary-source regulatory references — used with permission from the AI Centre of Excellence (MIT-licensed) and framed for pharmaceutical product trust. Every entry links to the issuing body's canonical text.
- [Regulatory hub](https://pharmaledger.org/regulatory): the regulations that govern product trust.
- [Clinical research](https://pharmaledger.org/regulatory/clinical-research): ICH E-series, GCP, FDA 21 CFR, research ethics, pharmacovigilance.
- [Healthcare](https://pharmaledger.org/regulatory/healthcare): HL7 FHIR/DICOM, health-data privacy, terminologies, SaMD.
- [AI governance](https://pharmaledger.org/regulatory/ai-governance): EU AI Act, NIST AI RMF, ISO/IEC 42001.
- [Data protection & privacy](https://pharmaledger.org/regulatory/data-protection-privacy): GDPR, UK GDPR, ISO 27701, NIST Privacy.
- [Cybersecurity](https://pharmaledger.org/regulatory/cybersecurity): NIST CSF/800-series, ISO 27001, NIS2/CRA/DORA, SOC 2.

## Case studies

- [ePI by PharmaLedger: electronic product information in 46 countries](https://pharmaledger.org/insights/case-studies/epi-by-pharmaledger): How a Novartis-led EU consortium became the production infrastructure delivering approved medicine information in 29 languages — from a scan of the pack.

## Pages

- [Home](https://pharmaledger.org/): What the trust fabric is and who it serves.
- [Association](https://pharmaledger.org/association): Governance, membership, and the nonprofit behind the platform.
- [Trust Center](https://pharmaledger.org/trust-center): Live platform status, compliance posture (GDPR, GxP, 21 CFR Part 11), and document library.
- [Insights](https://pharmaledger.org/insights): Articles, guides, and an industry glossary (ePI, DSCSA, FMD, IDMP, FHIR, GxP).

## Contact

- Book a demo: https://pharmaledger.org/platform#start
- Become a member: https://pharmaledger.org/association