TGA Compliance Agent
Built with Greenix Digital
An internal agent that checks your work against TGA obligations before a regulator does.
Not available to buy yet, and not yet priced. Register and we will tell you when it is ready.
Why we are building it
The problem this closes
TGA compliance fails in the gaps between reviews. A label changes, a marketing claim goes out, a supplier document expires, a record is filed in the wrong place — each small, each individually survivable, and each discovered months later during an audit or after a complaint. The obligations are well documented and largely checkable, which is exactly the kind of work that suits a persistent agent rather than a quarterly review.
Contents
What it does
- Runs inside your environment against your own documents, records and content — not as an external service you upload sensitive material to.
- Checks advertising and promotional material against the Therapeutic Goods Advertising Code before it is published, including restricted and prohibited representations.
- Reviews product documentation, labelling and instructions for use against the applicable requirements for your goods class.
- Monitors record-keeping and document currency: supplier declarations, certificates, sponsor obligations and review dates, flagging what has lapsed or is about to.
- Produces an evidence trail for each check — what was assessed, against which requirement, when and with what result — so compliance can be shown rather than asserted.
- Escalates anything ambiguous to a named person rather than deciding it. Where the answer depends on judgement or on advice, it says so.
What it deliberately does not do
It is not regulatory advice and it is not a substitute for a regulatory affairs professional. It checks against published requirements and flags what it cannot resolve; it does not make submissions, does not determine your product classification, and does not certify compliance. Your sponsor obligations remain yours. Where an obligation is significant, have a qualified adviser review the position.
Why we build this one
Our healthtech work is where the TGA obligations became concrete rather than theoretical — standing up a pharmacy supplier business with technology and processes built to satisfy the regulator. This product is that engagement knowledge, made continuous.
Who it is for
Sponsors, manufacturers, importers and distributors of therapeutic goods — including pharmacy supply, medical devices and complementary medicines — that carry TGA obligations without a large in-house regulatory affairs function.
Format
Deployed inside your environment. Subscription with implementation support.
Status
In development. Commercial terms will be published with the first release.
Built with Greenix Digital.
Also in preparation
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Tell us you want this one
Registering your interest puts you at the front of the release and shapes what we finish first. If enough people ask for a different product before this one, we change the order.
A short first conversation, then a clear recommendation.
Tell us what the program is, where it is, and what has to hold up. If we are not the right firm, we will say so and point you to who is.