Cost has two main components: manufacturing (driven by format, ingredients, dosing complexity and order volume) and TGA listing costs, which vary significantly between an AUST L and AUST R pathway. We provide a detailed quote covering both, so you understand the full cost of getting to market, not just the manufacturing cost, which is a common gap in quotes from providers who don’t handle the compliance side.

This depends on your ingredients, doses and claims. AUST L (Listed) medicines use lower-risk, pre-approved ingredients and the sponsor self-certifies compliance, this is the pathway most vitamin, mineral and general wellness supplements fall under. AUST R (Registered) medicines involve higher-risk ingredients or claims and require full TGA evaluation before approval, taking considerably longer and costing significantly more. We assess your formulation and intended claims early in the project to identify which pathway applies, since it fundamentally affects your development timeline and cost.

Both are common. If you have a formulation from a previous manufacturer or formulation chemist, we assess it for TGA compliance and commercial manufacturability. If you’re starting from a concept, we work with formulation experts to develop a recipe based on your target ingredients, doses and claims, checking ingredient permissibility against TGA requirements at every step.

We work with TGA GMP-licensed manufacturers across hard capsules, tablets, softgels, liquid tinctures/drops and powder sachets. Every ingredient and its intended dose is checked against the TGA’s permitted substances list before we finalise a formulation, this is one of the most common places international brands trip up when launching in Australia, since ingredient rules genuinely differ market to market. We flag immediately if an ingredient isn’t permitted, along with viable alternatives.

Yes, you’ll receive samples during formulation to approve taste (liquids/chewables) or physical format (capsules/tablets) before any production commitment. Note that changes to formulation after TGA listing has commenced can require amendment or resubmission of your listing, so we aim to finalise formulation, dosing and claims before listing begins.

This varies significantly by pathway. For a straightforward AUST L product, expect 300Kg, with manufacturing and listing running largely in parallel. For an AUST R product requiring full TGA evaluation, timelines extend to 8-12 months. We give an honest, project-specific timeline early.

Your formulation is typically documented as your intellectual property, and the AUST L or AUST R listing is registered to you as the sponsor, not the manufacturer, meaning you can switch manufacturers in future if needed. Switching generally involves confirming your existing formulation can be replicated by a new manufacturer to the same specification, and updating sponsor and manufacturing details with the TGA.