TGA Sponsor

Regulatory Services Australia provides a truly independent sponsor service for the Therapeutics Goods Administration (TGA) in Australia.

Why you need a TGA Sponsor?

Australia is an attractive market to sell international medicines and devices.  Many foreign manufacturers sell their products here, but first they must meet our strict regulatory requirements. 

If you plan on importing, manufacturing or selling therapeutic products in Australia – medical devices, medicines or complementary medicines – or you wish to conduct a clinical trial, you are required by law to engage an Australian TGA Sponsor to start the process.

The TGA Sponsor works with you and a regulatory consultant to meet the technical requirements of the TGA registration process, resulting in an entry on the Australian Register of Therapeutic Goods (ARTG), which is a publicly accessible document. 

A TGA Sponsor thereafter becomes your conduit between the Therapeutics Goods Administration and you as the (foreign) manufacturer, taking responsibility for your product(s) in Australia. 

Why Use RSA as your TGA Sponsor?

RSA is different to most other sponsors.   We are not primarily a technical regulatory consultant, although we offer those services too.   We are not a distributor, though we can help you find the right distributor.  We have no conflict of interest.  We are not based internationally.  We are Australians, living and mainly working in Sydney, Australia. 

Above all, we are business people focussed on making sure you get accurate and impartial advice to help you make the right decisions to give your product(s) and your business the best chance of succeeding. 

If you don’t know whether it is worth selling in Australia, we can help you with market analyses and market intelligence.  We help clients find distributors or, if they are selling direct, help them find contacts with potential customers.

If you want to sell in Australia, the first piece of advice you will need is how best to structure your Australian enterprise to make it profitable and minimise the cost of selling in Australia.  Do you need to set up a company?  Do you need to register your (foreign) company in Australia? Or can you get by with just having a Sponsor in Australia?  Are your product(s) regulated by the TGA, do they fall within another Australian regulatory regime (eg AICIS) or can you sell in Australia without registering your products?

We can guide you through those considerations and explain the options available to you.

You will almost certainly need a regulatory consultant to help you deal with technical queries with the TGA.  Many of our clients come to us through a regulatory consultant who has recommended us.  We work with many regulatory consultants across Australia.  If you don’t have one, we will recommend one or more consultant for you to speak to, based on your product(s) and their expertise.

You may also need to find a distributor, or you have sales channels already organised and need importing, warehousing and despatching services.  We can help you in these areas as well.

If your best option is to establish a legal presence in Australia, we can help you all the way.  We can create a company for you, which will become the TGA Sponsor.  It needs an Australian as a director.  We can provide that person.  We’ll help you with accounting, tax and company secretarial services.  More than that, we can help with strategy, local management, business development, marketing, sales, recruitment and operations assistance.  That’s where RSA stands out from others – we have been CEO’s of businesses doing all those things.  We understand how to bring it all together to make it easy for you, as a foreign manufacturer, to feel comfortable that your local operations are being overseen by experienced business executives like yourselves.

If you choose us as your TGA Sponsor we stay close to you and work with you to make sure you avoid regulatory issues with your product(s), packaging or marketing.   

We can also help you in many other ways to structure and grow your business effectively.

Next Steps?

 We want to talk to you about your product(s), your company, your international sales elsewhere in the world and your aspirations for the Australian market.  We ask you what contacts you already have in our markets – a distributor, for example, or a regulatory consultant?  Do you need more information about the local markets or are you ready to get going?  

And we tell you about us – who we are, our experience and our services.

So what does it cost you to use RSA as your TGA Sponsor?  Our pricing is competitive.  We keep it simple, and fair.  We provide an informal cost estimate after we know which services you need, following by a formal proposal if you are happy to proceed.

We treat all information received as confidential but we will sign a NDA at any time.  To formalise arrangements we enter a contract with you setting out all the services contracted, pricing and general terms and conditions.