Thrive with total compliance
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.
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is the federal government Department of Health authority on the risks, usage, and disposal of chemicals. We are thoroughly experienced in registering businesses with NICNAS, navigating their regulations, interpreting reforms and updates enacted by legislation, and understanding what they mean in different states and territories.
Every chemical used in Australia or imported in finished products must be notified with NICNAS prior to their supply to the Australian market. What we do is review your products to assess the current status of your chemicals and formulations, complete necessary paperwork and prepare applications for submissions to NICNAS.
Cosmetics & Personal Care
Chemicals used in cosmetic formulations and certain types of soaps must be notified with NICNAS prior to their supply to the Australian market. NICNAS, the National Industrial Chemicals Notification and Assessment Scheme, is the authority on the risks, usage, and disposal of chemicals in products either manufactured in Australia or imported in finished products.
We are thoroughly experienced in registering businesses with NICNAS, navigating their regulations, interpreting reforms and updates enacted by legislation, and understanding what they mean in different states and territories. What we do is review your products to assess the current status of your chemicals and formulations, complete necessary paperwork and prepare applications for submissions to NICNAS.
Food & Beverage
Food Standards Australia and New Zealand (FSANZ) sets the standards for all food products. The Code regulates the use of ingredients, processing aids, colourings, additives, vitamins and minerals, and determines health and hygiene obligations in food handling. It also covers the composition of foods, including genetic modification, and mandates warning and advisory labels.
Our consultants are skilled in ensuring all food products conform to the standards set by FSANZ, including meeting the relevant nutritional and labelling requirements. We also specialise in assessing products that fall into both food and therapeutic product categories.
Pesticides, Herbicides & Veterinary Medicines
Agricultural chemicals and veterinary medicines (agvet chemicals) are regulated by the Australian Pesticides and Veterinary Medicines Authority (APVMA) and must be registered before they can be sold in Australia. The APVMA also conducts post-authorisation checks to assess whether chemical products, active constituents and licenced or permitted activities continue to comply.To be sure that your agvet chemicals are compliant with current statutory criteria, we prepare your applications for registration and consult on essential future steps.
I’m Not Sure!
Don’t worry, we do. With more than thirty years of experience in regulatory compliance, we have seen an incredibly diverse range of products go from manufacturing to supply to flourishing on the market.
From guiding you through Good Manufacturing Practices required by the relevant authorities and developing efficient processes and manuals, to covering all bases with labeling and meeting every current standard, our consultants have the experience and the expertise that you need to put a compliant product on Australian shelves.