The Therapeutic Goods Authority (TGA) regulates the manufacturing, supply, import, export and advertising of therapeutic goods: pharmaceutical (drugs), biological, topical, medicinal and other. The TGA is vigilant in their assessment and monitoring of pre- and post-market goods and it is vital, for your consumer and the health of your business, to be vigilant also. For over thirty years we have specialised in registration and listing of therapeutic goods, from prescription, over-the-counter and traditional medicines to vitamins, minerals and antiseptic products.

We also deal with applications for Class I and Class II medical devices, and many other types of active and non-active devices, for inclusion on the Australian Register of Therapeutic Goods (ARTG). All medical devices must be included on the ARTG, which is regulated by the TGA, before being supplied in Australia.

You will also need to be aware of the Good Manufacturing Practices required by the TGA. We can develop procedures and manuals that ensure your manufacturing complies with the regulations, as well as conduct deficiency response audits and train your staff, where necessary.