Understanding the constraints of operating in a regulated marketplace can be the difference between product success or failure in Australia.
The regulatory requirements for these sectors are complex, and constantly changing. Ensuring that your business and products comply with the regulatory requirements of government agencies such as The Therapeutic Goods Administration (TGA), National Industrial Chemicals Notification and Assessment Scheme (NICNAS), and the Australian Quarantine and Inspection Service (AQIS) can be challenging.
This is where an experienced regulatory consultant can provide a value added service to your business.
The ingredients in a product, the claims made, and how a product is presented may all contribute to determining if your product is regulated as a therapeutic good.
Understanding how these regulatory controls impact on your product is critical to be able to position your product to maximize your business objectives.
Products that sit on or near the boundary between medicines, medical devices, cosmetics or foods can be challenging for businesses to determine how to proceed.
Knowledge of the regulatory requirements is critical to provide advice on the most business appropriate pathway for your product.