Regulatory Affairs Consultants
Helping you understand the regulatory framework for Australian therapeutic goods, including complementary and listed medicines, and low-risk medical devices, is our forte.
All of our staff have worked for Australia's national medicines regulator, the Therapeutic Goods Administration and understand the principles of this regulatory framework from lived experience. We were managers, reform experts, and technical evaluators who learned what a good evidence package looks like.
We can help you submit applications for the evaluation of new ingredients and medicines that will be introduced to the Australian market or review your existing products to make sure that they are compliant with the requirements.
We know how to help you to prevent common mistakes that Australian sponsors make. We can even develop a tailored training package for your team and teach you how to navigate the framework for your day to day operations.
Government Operations & Policy Experts
Our team of former public servants offer professional services based in lived experience and best practice.
Our consultants understand what it means to develop regulatory policy in order to deliver services that maintain good governance, appropriately regulate industry, and keep the public safe.
We know what it means to take a risk-based approach to regulation which considers actual risk of harm and the regulatory and non-regulatory options available to respond to it.
If there's one thing we can do better than anyone else, it's undertaking a detailed review of your regulatory operations, and finding ways to help you do more with your existing resources. We can help you manage anything from large-scale regulatory reform projects to smaller reviews of your own internal policies and procedure. Get in touch to learn more about how we can help you.
TGA declares some sports supplements to be medicines
The TGA has declared two broad categories of sports supplements to be therapeutic goods. These products must transition to the medicines framework within 10 weeks or 3 years, depending on the product type.
The TGA has fined Zafe Zone almost $40,000 for allegedly promoting its disinfectant as effective against coronavirus, without having the necessary approvals from the TGA.
The TGA is targeting traditional indications
The TGA is undertaking a targeted review of medicines making traditional claims in the second half of 2020. Learn more about how to prepare your product range.