Regulatory Services

Regulatory Services

If you’re 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, CMG 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.

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:

Claims formulation and substantiation

  • Listed medicine applications
  • Evidence packages
  • Label development and reviews
  • Advertising reviews
  • GMP preclearance for overseas manufacturers
  • Review of product specs and documentations
  • Response to section 31, request for information from the TGA
  • ACCM applications
  • Proprietary ingredient notifications
  • Liaising with the TGA

We can also assist in addressing other issues that may arise during the process of bringing a product to market, and during post market monitoring.

For more information contact Craig:

Contact Us

  • 5a/5b Jubilee Avenue, Warriewood, NSW, 2102, Australia
  • 02 9091 0264

Request a Quote

Would you like a quote for your new product concept or talk to our sales department?

Contact: Craig Fallshaw

Teams Meeting

Contact Craig for a

Teams Meeting