Australia (TGA)
Therapeutic Goods Administration listing and ARTG pathways.
Service · Regulatory Compliance
Regulatory compliance & multi-market registration
Regulatory compliance is the difference between a product that sells and a product that sits in a warehouse. We map the pathway before anything goes to print.
Scope
Markets we cover
European Union (CPNP)
Cosmetic Products Notification Portal submissions.
United Kingdom (SCPN)
Submit Cosmetic Product Notification for the post-Brexit UK market.
GCC (SFDA)
Saudi Arabia, UAE, Kuwait, Bahrain, Qatar and Oman.
Southeast Asia
Malaysia, Indonesia and Singapore.
Multi-market packages
One coordinated strategy across several jurisdictions at once.
Protocol
What you receive
- 01
Ingredient review
Market-specific screening against each regulator's permitted list.
- 02
Pathway recommendation
The route to market, with the evidence each regulator will ask for.
- 03
Label & claim scoping
Compliance review of the label, and claims graded against the literature.
- 04
Dossier & submission
Documentation prepared and lodged through the relevant portal.
For Australian brands planning to export, international brands entering Australia, and founders launching across several markets at once.
Questions
Questions we're asked about market entry
Which markets can you take a product into?
The TGA in Australia, CPNP in the European Union, SCPN in the United Kingdom, SFDA across the GCC, and the Southeast Asian regulators in Malaysia, Indonesia and Singapore. Several markets can run as one coordinated strategy rather than one after another.
Can you tell me which claims I am allowed to make?
Yes. Claims are graded against the published literature and against each regulator's permitted indications, so you know which survive scrutiny and which need rewording, before the label goes to print rather than after.
What happens if an ingredient is not permitted in my target market?
It is flagged during the ingredient review and we propose alternatives that hold the formula's intent. Finding it at submission, with packaging already printed, is what costs months.
Do you lodge the submission, or only prepare it?
Both. The dossier is prepared and lodged through the relevant portal, and the documentation stays with you afterwards.
How long does registration take?
It depends on the market and on the regulator's own queue. We scope an indicative timeline per jurisdiction in the proposal rather than promise a date that is not ours to control.
Can you review a formula we already have?
Yes. An existing formula can be screened against a target market's permitted lists and its claims assessed against the evidence, before you commit to the launch.
Next step
Begin with a 30-minute discovery call
A focused conversation to understand your product and scope what's possible. No pressure, no pitch.