Professional Services
If your thinking about bringing out a single product or launching a new product range; if you want to update a current product range; or if you simply want advice on how to label a food product so that is compliant with the Food Standards Code, Rachael Keenan Consulting can help.
Most people are unfamiliar with the Australian therapeutic goods regulatory environment, and can be overwhelmed by the processes of product development, listing or registration, manufacturing and post market reviews. With extensive experience and a vast network of industry contacts, we can prevent this confusion and help you to bring to the market a product that is fully compliant with the regulatory requirements.
Complimentary Medicines
In Australia complementary healthcare products are classed as medicines and must be listed or registered on the Australian Register of Therapeutic Goods (ARTG) through the Therapeutic Goods Administration (TGA). We can facilitate all aspects of this process by providing the following specialist services:
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Product Research & Development
New products are always appearing on the market, and suppliers of therapeutic goods want to keep up with current research and trends. Rachael Keenan Consulting can assist with new product research and development and in the reformulation of existing products by developing suggested formulations according to your requirements. Once you have decided on an appropriate formulation, we can liaise with contract manufacturers and suppliers of raw materials to facilitate a timely launch of your new product.
Technical Writing & Advertising Material
The advertising of therapeutic goods in Australia must comply with the Therapeutic Goods Advertising code, and most types of advertising material requires approval prior to printing. Rachael Keenan Consulting can write advertising material or review advertisements and promotional material before approval and printing to ensure that it complies with the code, saving you time during the approval process.
Product manuals, technical articles and newsletters are an important part of the marketing of a new product, or the ongoing marketing of an existing product or product range. We can provide information that is technically accurate, and that reads easily and effectively. It is important to remember that product-specific information must also comply with the Therapeutic Goods Advertising Code, and we can ensure that these regulations are met.
Foods
In Australia foods do not have to go through the approval process that applies to therapeutic goods, however, all food ingredients, packaging, promotional material and claims on food products that are manufactured or imported and sold in Australia and New Zealand must comply with the standards set by Food Standards Australia New Zealand (FSANZ).
We can advise you on whether your product is a therapeutic good or a food and can ensure that your food products comply with the FSANZ Food Standards Code. We can also advise on claims that you may wish to make regarding your food products. In addition, we can advise you if a product that you are importing into Australia requires an import permit from Australian Quarantine Inspection Services (AQIS), and we can obtain this documentation for you.
Cosmetics
Cosmetic products in Australia must be labeled in accordance with the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991, and they must only contain ingredients that are listed on the Australian Inventory of Chemical Substances without restriction for use in cosmetic products. If a cosmetic product makes a claim that would be considered a therapeutic indication, the product would then be considered a therapeutic good, and would need to be listed or registered on the ARTG. We can review the formulation and labels of cosmetic products to ensure that they comply with the necessary regulations, and we can advise on claims that can be made for your products that are appropriate for cosmetic products and to ensure that they do not fall into the category of therapeutic goods.