Human Therapeutics / Medicines

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

De Groot Technical Services provide solutions to your regulatory headaches, helping you turn your ideas into a success.

> Are you looking for help to get approval for a prescription medicine, OTC 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 pharmaceutical product development?
> Do you need advice on importing pharmaceutical/chemical products into Australia or exporting them from Australia?
> Do you require professional scientific report writing?

The experienced and efficient team at De Groot Technical Services 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 excipient 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 can also offer an efficient, flexible and customised solution to meet your specific needs.