REGULATORY AFFAIRS CONSULTANTS

WE HELPED DESIGN THE SYSTEM

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NEED HELP UNDERSTANDING YOUR REGULATORY REQUIREMENTS?

Our regulatory affairs consultants can help you figure out if your listed or complementary medicine (also known as a dietary supplement or natural health product) is captured by Australian laws and help you meet your legal requirements.

Our team is made up of former TGA staff who are regulatory and technical experts who helped build the system.

We can help you to bring a new ingredient, listed or complementary medicine, or low-risk medical device to the Australian market in a way that meets your regulatory obligations.

We have decades of experience with regulating these products and with helping industry make sense of their regulatory obligations.

As members of Consumer Healthcare Products Australia and ARCS, we are proud to offer a world-class service to meet your needs. Contact us to learn more about how we can help you, or you can check out our regulation cheat sheets.

Regulatory Affairs

Medicines that are supplied in Australia must comply with the Therapeutic Goods Act 1989. We can help you understand your obligations and prepare the right evidence dossiers

Our regulatory affairs consultants can take away the difficulty in understanding your regulatory obligations and make sure that you bring a compliant complementary medicine to the market.

We can help you create the right evidence packages for your product type.

Training

We create training packages tailored to your needs and budget to ensure you have all the in-house expertise that you need.

Evidence Reviews

We make sure that you've got the right evidence to support your health and non-health claims, keeping your products compliant and innovative. You will have ongoing legal obligations once your medicine is being supplied in Australia. These include making sure you hold evidence to support all claims that you make about the medicine. We specialise in responding to post-market compliance reviews from the TGA so you no longer have to worry about whether you're doing all the right things.

Label reviews

We can help you create a compliant labels or help you transition from TGO 69 to TGO 92. We can also check your compliance with advertising requirements

Government liaison

We can help take the difficulty out talking to the TGA and open the communication channels between you and the regulator. The laws regulating complementary medicines are changing following the Expert Review into Medicines & Medical Devices. These changes have started to come into effect and will continue for the next few years. We can help you plan for these changes over the transition period so that your products remain compliant into the future.

Appealing TGA Decisions

If you find yourself disagreeing with TGA's decision, get in touch with us so that we can guide you through this process.

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Getting Help understanding changes to the Regulations

The regulatory framework for therapeutic goods is changing, presenting industry with better incentives for innovation. To understand how these changes will impact your products, get in touch. Our experts can help you make the most of these changes.

Our work in this space means that when you are looking for the most competent and experienced complementary medicines regulatory affairs consultants, the team at Avicenna Consulting is the obvious choice!

Contact us to learn more

Our services can be tailored to your needs. Contact us to find out how Avicenna Consulting can help you manage your regulatory obligations.