Pharma Track and Trace

Pharmaceutical track and trace.
DSCSA compliant.

ProtectCode pharmaceutical track and trace software meets DSCSA unit-level requirements for pharmaceutical manufacturers selling into the US market. Track every pharmaceutical unit from manufacture through the distribution chain to the point of dispense.

GS1 Digital Link ready
Self-service SaaS
26 countries deployed

Platform facts

Self-service

No implementation project. Live within 30 days of first print run.

1,000+

Brands globally

26

Countries

ASX: CDE

Codeifai Limited. Publicly listed. Transparent. Accountable.

How it works

Pharmaceutical track and trace. DSCSA compliant. explained.

The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical manufacturers to implement unit-level track and trace for every product sold into the US market. This means a unique product identifier on every unit and the ability to produce a chain of custody record on request.

ProtectCode meets this requirement through unit-level serialised QR codes applied at manufacture. Every scan through the pharmaceutical distribution chain creates an automatic chain of custody record. The BrandReporter supply chain intelligence platform provides the regulatory documentation on demand.

DSCSA unit-level track and trace for US pharmaceutical market

EU FMD compliant for European pharmaceutical distribution

Chain of custody documentation on demand from scan records

Consumer and pharmacist authentication at point of dispense

Pharmaceutical diversion monitoring via rules-based alerts

API integration with wholesale and pharmacy systems

Key capabilities

Unit level

Every individual product tracked, not batches or shipments

Real-time

Data updated live with no processing lag

Global

Works across every market and distribution channel

Use cases

Where it makes
the difference.

ProtectCode is deployed across FMCG, pharmaceutical, wine, cosmetics, and
export-focused industries globally.

DSCSA compliance

Unit-level track and trace meeting Drug Supply Chain Security Act requirements for every pharmaceutical unit sold in the US.

EU FMD compliance

Falsified Medicines Directive track and trace for pharmaceutical manufacturers in EU member state markets.

Chain of custody documentation

Transaction history and chain of custody records generated automatically from scan data. Available on demand for regulatory audit.

Point of dispense authentication

Pharmacists and patients verify authenticity at dispense using standard smartphone camera. Instant verification, no app required.

Recall and withdrawal

Unit-level tracking enables targeted pharmaceutical recalls. Specific production batches identified and withdrawal documented from scan records.

Diversion monitoring

Pharmaceutical products appearing in unexpected markets or channels surfaced through rules-based monitoring of geographic scan data.

Common questions answered.

Does ProtectCode meet DSCSA track and trace requirements?

Yes. ProtectCode meets the unit-level product identifier and chain of custody requirements of the Drug Supply Chain Security Act for pharmaceutical manufacturers selling into the US market.

What DSCSA documentation does ProtectCode generate?

ProtectCode generates transaction history, transaction information, and transaction statements from supply chain scan data automatically. This documentation is available on demand from the BrandReporter dashboard.

Can pharmaceutical track and trace data be exported?

Yes. All ProtectCode scan and chain of custody data is exportable via the dashboard or REST API for integration with regulatory submission systems.

Does pharmaceutical track and trace require existing IT infrastructure changes?

No. ProtectCode is a self-service cloud SaaS platform. Integration with existing pharmaceutical manufacturing ERP and wholesale distribution systems is via REST API. No on-premise installation or infrastructure changes required.

Pharmaceutical track and trace that meets the standard.

Book a demo and see DSCSA-compliant track and trace running on a pharmaceutical product.