An overseas pharmaceutical, biotech or medtech company normally needs an Australian company to supply products here (the TGA sponsor), to sponsor clinical trials, and to claim the R&D tax incentive. We register the Pty Ltd, provide the resident director and registered office, and handle ABN, GST and R&D claims, working alongside your regulatory consultant and CRO.
Overseas pharmaceutical, biotech and medtech companies come to Australia for three reasons: to sell products here, to run clinical trials, and to claim one of the most generous R&D incentives in the world. Each of these needs an Australian company. We set that company up and keep it compliant, so your regulatory consultant and CRO can get on with the TGA and the trial.
Why you need an Australian company
- To supply medicines or devices: a TGA sponsor. Therapeutic goods must be on the Australian Register of Therapeutic Goods (ARTG) before they can be sold, and the application is made by the Australian sponsor. The TGA requires a sponsor to give an Australian street address and an ABN or ACN, and to keep at least one Australian representative at all times.
- To run a clinical trial: an Australian trial sponsor. Under the TGA's Clinical Trial Notification (CTN) scheme, the notification is submitted by the Australian clinical trial sponsor, which needs its own TGA client ID and is responsible for having the ethics and site approvals in place.
- To claim the R&D tax incentive. Only an Australian R&D entity can claim. If your group's worldwide turnover is under $20 million, the offset is refundable: 43.5% of eligible spending for most companies, paid in cash when the Australian company is in tax loss.
Hundreds of overseas life sciences companies already do this
The ATO publishes every R&D tax incentive claimant. Its 2023-24 data, released in September 2026, lists 929 foreign-owned claimants. Our analysis of that list found:
| Who | Companies | R&D expenditure 2023-24 |
|---|---|---|
| Australian subsidiaries of global pharmaceutical groups (MSD, Roche, Bristol Myers Squibb, Eli Lilly, AbbVie, AstraZeneca and others) | 17 | $340 million |
| Companies named in the overseas biotech style, such as Keros Therapeutics Australia Pty Ltd and Arcus Biosciences Australia Pty Ltd | 137 | $261 million |
The typical overseas biotech subsidiary reported $1.2 million of R&D spending, which at 43.5% is a cash refund of about $520,000. The second group is identified by company name, so it is an estimate: it misses companies named differently and may include a few Australian-owned ones.
Your own sponsor company, or a third-party sponsor?
Some regulatory consultancies will act as your TGA sponsor for a fee. That can suit a single product with no other Australian activity. Your own Australian company usually makes more sense once you plan trials, staff or several products.
| Third-party sponsor | Your own Australian company | |
|---|---|---|
| Who holds the ARTG entries | The consultancy, as sponsor | Your company |
| Changing provider later | Entries have to be moved to a new sponsor | No change: you change consultants, not sponsors |
| Clinical trials and the R&D tax incentive | Not available to you through the consultancy | Your company sponsors trials and claims the incentive |
| Staff, contracts, importing and GST | Not covered | Your company employs, contracts and imports in its own name |
| Setup effort | Low | Company registration and ongoing compliance, which we handle |
What we set up
- Australian Pty Ltd registration with ASIC, usually within 1 to 3 business days once details and consents are in: From $900 (+ $636 ASIC fees).
- Resident director. Every Pty Ltd needs at least one director who ordinarily lives in Australia: From $6,000/yr + GST. See resident director services.
- Australian registered office and street address for ASIC and for your TGA organisation details: From $500/yr (North Sydney or Gold Coast).
- ABN, TFN and GST registration, so the company can be registered with TGA Business Services and claim GST on imports and trial costs: From $600 (non-resident bundle).
- Bank account support for overseas-owned companies: From $500.
- R&D tax incentive registration each year and the claim in the company tax return. See our R&D tax incentive service.
- Ongoing compliance: ASIC annual review, tax returns, payroll if you hire. See ongoing compliance.
Most clients start with our Subsidiary Pty Ltd Package, From $8,500 for the first year. We are accountants and corporate service providers, not regulatory consultants: your regulatory affairs agent prepares the TGA applications and your CRO runs the trial. We work alongside both.
How it works
- Structure call. We confirm who will own the Australian company, who owns the trial data and IP, and whether your group turnover allows a refundable R&D offset.
- Company registration. Director IDs, consents, constitution and ASIC registration, then ABN, TFN and GST.
- TGA Business Services. Your company, or your regulatory agent on its behalf, registers the organisation with the TGA and receives a client ID for ARTG applications or CTNs.
- Contracts in the company's name. CRO, sites and laboratories contract with the Australian company, so the spending is its own for the R&D claim. If the overseas parent will own the results, put a written R&D agreement in place first. See R&D for a foreign parent company.
- Each year. Register the R&D activities within 10 months of year end, lodge the tax return with the R&D schedule, and keep ASIC and TGA details current.
Request a quote
Tell us a bit about your situation. We reply the same business day with a fixed-fee quote.
Frequently asked questions
Can an overseas company be a TGA sponsor?
Not from overseas. The TGA requires the sponsor to have an Australian address and ABN or ACN and to keep at least one Australian representative at all times. Overseas manufacturers either appoint a third-party Australian sponsor or set up their own Australian company.
Does a foreign biotech need an Australian company to run a clinical trial?
The CTN is submitted by the Australian clinical trial sponsor. Most overseas biotechs set up an Australian Pty Ltd to be that sponsor, because the same company can then claim the R&D tax incentive on the trial costs. See clinical trials and the R&D tax incentive.
How much is the Australian R&D tax refund for a biotech?
If group turnover worldwide is under $20 million, the refundable offset is 43.5% of eligible R&D spending for most companies. A trial costing $5 million in Australia could return about $2.2 million in cash. Above $20 million, the offset is non-refundable and reduces tax payable instead. See aggregated turnover for foreign groups.
Do you prepare TGA applications?
No. We set up and run the Australian company. ARTG applications, CTNs and regulatory strategy are handled by your regulatory affairs consultant, and we can coordinate with them.
How long does setup take?
ASIC registration usually takes 1 to 3 business days once director IDs and consents are in place. Allow extra time for overseas director ID applications, the bank account and TGA Business Services registration.