In Australia, the Therapeutics Goods Administration (TGA) is the governing body whose job is to regulate therapeutic products. The most prominent of them all is prescriptions, over-the-counter medicines(AUST-R), complementary medicines (AUST-L) such as herbs, vitamins, nutritional supplements, and medical devices.
TGA ensures access to quality therapeutics goods for the population and protects the masses by enacting laws under the Therapeutics Goods Act 1989.
Thaeta assists you in overcoming the regulatory hurdles, so you can convert your business idea into a success story.
- Are you looking for an approval from the governing body TGA for over-the-counter medicines or complementary medicines so you’ll be legally entitled to market them in Australia?
- Do you intend to register the therapeutics goods on the Australian Register of Therapeutic Goods (ARTG)?
- Are you looking for someone to provide you with regulatory advice on therapeutic product development?
- Do you need a regulatory guide for importing products to Australia or exporting them from Australia?
- Do you need a trained professional to prepare a professional scientific report writing?
If you are the person who has all or some of the above-mentioned business needs, consider seeking consultancy.
Our experienced and competent team at that can assist you in fulfilling each of these requirements, by:
- Providing complete hand-holding support and technical assistance for application submission, labeling, and product reviews of complementary medicines and OTC medicines.
- Reviewing your existing product formulation data and give counseling on the eligibility of the product and the amount of documentation required for the registration of the product in Australia
- Assisting in the listing of your product on the Australian Register of Therapeutic Goods (ARTG) or in case you want to modify the recipient of the product after listing on the ARTG.
- Giving recommendations on the compliance of product advertising and promotional material, particularly brochures, social media ads, magazine ads, TV commercials, and websites.
- For complimentary and OTC medicines, we can coordinate the generation of evidence to streamline the product registration process. Additionally, we will inform you about any possible claim on the product label or the promotional material beforehand so you can offset the potential threat of any litigation.
- Suggesting medicine/poisons scheduling
- Offering the most feasible and customisable solutions to address your business solutions.