Industries

Pharma & Life Sciences

The TGA's Good Wholesaling Practice code makes cold-chain and traceability a licence condition

Supply chain compliance in pharma is a traceability problem first. We build the systems that track it.

Pharma and life sciences supply chains need batch and cold-chain traceability, and compliance documentation tooling that holds up under audit. We build the traceability and compliance workflow tooling this vertical needs, sized to mid-market distributors and manufacturers.

  • Batch & cold-chain traceability
  • Compliance documentation workflows
  • Recall & batch lookup tooling
  • Regulatory submission & audit-trail reporting
Why Now

The TGA's Good Wholesaling Practice code makes cold-chain and traceability a licence condition

The TGA's Australian Code of Good Wholesaling Practice requires documented cold-chain management, temperature monitoring in transit, and traceable distribution records for Schedule 2, 3, 4, and 8 medicines — with licence suspension or a forced recall as the consequence of failing to produce them.

01
What It Requires

Documented cold-chain handling, temperature-monitoring records, and batch-level distribution traceability that a TGA inspection or recall can be run against directly — not a paper trail assembled after the fact.

02
Who It Affects

Mid-market pharma distributors and manufacturers holding a wholesale licence under the TGA Good Wholesaling Practice code, many still tracking batch provenance and cold-chain records manually.

03
Cost of Inaction

Gaps in cold-chain or traceability records risk licence suspension or a forced recall under TGA requirements — not just an audit finding.

What We Build

Traceability and compliance workflow tooling for mid-market pharma supply chain teams.

01

Batch & Cold-Chain Traceability

Systems that track batch provenance and cold-chain handling from receipt through distribution, built to the TGA's Good Wholesaling Practice documentation and temperature-monitoring requirements.

Integrates with your existing warehouse and distribution process.
02

Compliance Documentation Workflows

Structured documentation and record-keeping workflows that reduce the manual paper trail compliance audits currently require.

Replaces manual, paper-based record-keeping directly.
03

Cold-Chain Temperature Monitoring Integration

Integration with temperature-logging hardware and sensors, so cold-chain excursions are flagged and recorded automatically instead of read off a logger after the fact.

Feeds directly into the batch traceability record for the shipment.
04

Recall & Batch Lookup Tooling

Fast batch-to-shipment lookup built for the moment a recall or product hold happens, when finding every affected unit quickly is the entire requirement.

Queries the same batch and cold-chain records used for day-to-day traceability.
05

Regulatory Submission & Audit-Trail Reporting

Structured export and reporting tooling that turns tracked batch and compliance data into audit- and submission-ready documentation on demand.

Sits on top of the batch traceability and documentation layers.
06

Distributor & Pharmacy Portal Integration

Status and provenance visibility for downstream distributors and pharmacies, reducing the manual confirmation calls that slow down dispatch.

Integrates with your existing distribution and order management process.

Not sure which of these fits your team? Tell us where the gap is and we'll scope it together.

How We Engage

A shorter first engagement, scoped to the highest-risk traceability gap.

01

Traceability & Compliance Review

We assess your current batch tracking and documentation process to find where paper or fragmented systems create audit risk.

02

Scoped Sprint Plan

A fixed-price sprint plan targeted at your highest-risk gap first — usually batch traceability or cold-chain monitoring — sized to prove the approach before a larger rollout.

03

Build on Django/DRF + React

An auditable, integration-friendly stack: Django/DRF backends built for data integrity and audit logging, React interfaces your team can use without training sessions.

04

Compliance Review Before Launch

We validate the traceability and documentation workflow against the compliance requirement it addresses — including TGA Good Wholesaling Practice conditions — before go-live, not after, when a gap becomes a licence issue.

05

Fixed-Price, Short Cycle

A scoped, fixed-price first build targeting one traceability or documentation gap, sized to prove the approach before a larger rollout.

Work With Us

Book a Free Scoping Call.

Get on a call and walk away with a 1-page build plan within 48 hours — what we'd build, how long it'd take, and what it costs.

What to expect
  1. 1We review your brief
  2. 2You get a call confirmation
  3. 3Walk away with a 1-page build plan
No sales pitch — just a clear build plan.