Pharmaceutical serialization & track-and-trace platform
Prove every product.Answer every audit.
One tamper-evident record of every product, from line to patient, for manufacturers, CMOs, wholesalers, and 3PLs.
Passed Powered by Hyperledger Fabric and Hedera, an enterprise-grade distributed ledger.
The audit isn't the problem.
The scramble is.
If an inspector asked you to trace one suspect unit right now? How long would it take? An hour? A week?
For most teams, the honest answer lives across the packaging line, the ERP, a 3PL's warehouse system, and a partner portal nobody controls. So quality rebuilds the story by hand, export by export and email by email. Every gap is risk: held shipments, failed verifications, findings on your record, and hours your team doesn't have.
Not sure where your gaps are?Get the DSCSA Checklist
Data you can't defend.
Spreadsheets and siloed systems produce records a partner or an auditor can question.
Visibility that ends at your dock.
Once product ships, you see only what partners choose to share. Counterfeits enter in the blind spots.
Recalls slower than the risk.
Notifying every affected partner by phone and email takes days the patient doesn't have.
One record everyone can trust, including the regulator.
Deploy modules standalone or as a full suite, alongside the ERP and line-level systems you already run.
From line to patient, in three steps.
Serialize
Assign GS1-compliant unique identifiers at unit, case, and pallet level or connect the serialization you already have.
Record
Every movement, handoff, and status change writes to the shared, tamper-evident ledger in real time.
Prove
Verify authenticity at any point in the chain, resolve exceptions, and produce audit-ready reports on demand.
Built for your seat in the chain.
Ship product that proves itself.
Serialize at source, exchange data with every downstream partner, and release with records that hold up.
Verify in seconds. Move product, not paperwork.
Verify authenticity on receipt, clear saleable returns in minutes, and catch exceptions at the dock.
Every pack you dispense, verified.
One scan shows a product's full journey, protecting the patient in front of you and the license behind you.
Chosen over the established players.
Two concrete outcomes, not adjectives.
Evonik selected PharmaTrace for traceability across its packaging operations, choosing a fit-for-purpose platform over established names in the space.
A cannabis wholesaler in New Zealand uses PharmaTrace to track batch-level compliance, replacing dozens of manual paper trails with one shared record.
A team of AI agents
that does your manual work,
while you stay in control.
They review exceptions, check partner data, and prepare your compliance evidence, so you spend less time chasing information and more time deciding what to do about it.
PharmaTrace holds your data and records. Agents read this information and add their findings, they don't edit it. Every regulated action still needs a person to approve it before it happens. No record changes and nothing gets submitted without sign-off.
What they do
Built by people who've lived the audit scramble.
Issame Outaleb spent years as a business strategist and consultant inside biotech and pharmaceutical companies helping them design the strategy, processes, and systems behind product launches and operations.
Across those engagements, he kept seeing the same gap: the compliance data these companies needed to defend themselves lived in disconnected systems, rebuilt by hand under pressure, every time. He built PharmaTrace, and the team behind it, to close it.
Not ready for a demo? Start with the checklist.
The DSCSA Readiness Checklist: 20 questions your next auditor will ask and how to know you can answer every one.Get the DSCSA Checklist
Straight answers.
Does PharmaTrace replace our existing serialization systems?
No, unless you want it to. The platform is modular: run it alongside your ERP and line-level systems, or deploy serialization standalone where you have gaps.
Who owns our data?
You do. You control what's shared, with which partners, at what level of detail. The ledger is built to make any change to a record detectable, not to open access.
What if we leave? And how does an immutable ledger square with GDPR erasure rights?
Your records can be exported in standard formats, with no lock-in. Personal data is kept off-chain by design, so erasure requests never collide with the immutable event ledger.
Do regulators accept blockchain-based records?
DSCSA and EU FMD define what you must capture and exchange, not the database behind it. An immutable ledger strengthens the data-integrity expectations inspectors already apply.
Which standards do you support?
GS1 identifiers and any other applicable serialization standard, with workflows built for DSCSA and EU FMD.
What does it cost?
Pricing scales with modules and volume. Book a demo and we'll scope it in the first conversation, not at the end of a sales cycle.
Your next audit is already on someone's calendar.
Walk in with the answer. Book a 30-minute demo mapped to your supply chain. If we're not the right fit you'll still leave knowing exactly where your traceability gaps are.
Book a Demo