Regulatory affairs

All medicines in Australia, including complementary medicines, 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, from the formulation and review of evidence-based therapeutic claims for products with appropriate substantiating evidence, to the compliation and submission of applications to the TGA, and the development and review of product labels.

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. 

 

E-mail: rachael@rkeenanconsult.com.au