Hands-on support with manufacturing requirements and product applications. Understand the work ahead, bring the right information together and move your project forward.
For Australian sites, the relevant pathway is manufacturing licensing. Overseas sites may require GMP clearance or certification, depending on the circumstances.
Review the site, activities and available evidence
Identify information gaps and priorities
Coordinate preparation, specialist input and application follow-up
GMP clearance for an overseas manufacturing site is obtained by the Australian sponsor, or an agent acting on its behalf.
02 / PRODUCT OWNERS
Bring the product application together.
The route into the Australian Register of Therapeutic Goods (ARTG) depends on the product. For complementary medicines, this may involve listing, assessed listing or registration.
Clarify the product, ingredients and intended claims
Coordinate manufacturer and supporting documents
Assist with preparation and the right application pathway
The ARTG entry is held by an Australian sponsor, whose role should be agreed as part of the project.
PROJECT COORDINATION
Turn requirements into a working plan.
Keep the product, manufacturing and documentation work connected. We help organise the moving parts and coordinate with the relevant manufacturers and technical specialists.
ClarifyWhat you are making, where it is made and the market you want to reach.
PrepareA prioritised work plan and the information needed from each party.
CoordinateQuestions, documents and follow-up across the project.
A REAL MANUFACTURING PROJECT
From preparation to Australian representation.
In 2026, an overseas manufacturer received its TGA GMP certificate after an on-site TGA inspection. We helped it prepare, and now represent it in Australia; two Australian brands are already working with it.
Does every health or personal care product need to be included in the ARTG?
Product classification comes first. Ingredients, intended use and claims help determine whether a product falls under therapeutic goods, food or cosmetics requirements.
Can you help with both factories and products?
Yes. We can discuss manufacturing-related preparation and product application support, with the scope shaped around your facility, product and market.
What should I bring to the first conversation?
Your product category, intended market and any available formula, manufacturer or project information. We can then agree the next step and the support required.
