Therapeutic Goods Compliance

In Australia, the Therapeutic Goods Administration (TGA) regulates therapeutic products; including prescription and Over The Counter medicines (AUST-R), complementary medicines (AUST-L: for example herbs, vitamins and nutritional supplements) and medical devices.

DTS provide solutions to your regulatory headaches, helping you turn your ideas into a success.

  • Are you looking for help to get approval for over-the-counter medicines or complementary medicines with TGA so as to market them in Australia?
  • Do you wish to register Therapeutic Goods onto the Australian Register of Therapeutic Goods (ARTG)?
  • Are you interested in regulatory advice for therapeutic product development?
  • Do you need advice on importing chemical products into Australia?
  • Do you require professional scientific report writing?

The experienced team at DTS can assist you in each of these areas by:

  • Providing professional regulatory and technical advice, with application submissions, labelling and product reviews of complementary medicines (or dietary supplements) and OTC medicines.
  • Reviewing your existing product formulations data, and advise on eligibility of products and level of registration required in Australia.
  • Assisting with listing of your product on the Australian Register of Therapeutic Goods (ARTG) or changing of recipient of your product after listing on the ARTG.
  • Advising on compliance of product promotional material including labels, packaging, brochures, display stands and websites.
  • For complementary and OTC medicines, we can coordinate the generation of evidence to support your product registration and advise on possible claims on product labels and promotional materials.
  • Providing advice on medicine/poisons scheduling.
  • We also offer a flexible and customised solution to meet your specific needs.