Avicenna Consulting: Complementary Medicines Therapeutic Goods Regulatory Affairs

REGULATORY AFFAIRS CONSULTANTS

EXPERTS WITH EXPERIENCE AS REGULATORS

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 a wealth of experience with regulating products including vitamins and minerals, sports supplements, prebiotics, probiotics, and postbiotics, fibre, and novel products and with helping industry make sense of their regulatory obligations.

As members of Complementary Medicines Australia, 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.

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 from the new product development stage through to post-market compliance

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. 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. We can even undertake literature reviews for you and prepare TGA-compliant efficacy packages to support your indications.

Label reviews

We can help you ensure that your labels are compliant with all requirements - including the claims made, therapeutic goods labelling order, and advertising requirements.

Manufacturing quality

We offer regulatory affairs support to ensure top product and ingredient quality. Our services include reviewing raw ingredient specifications, stability data, product specifications, and certificates of analysis, ensuring regulatory compliance and product integrity.

We can even help you to ensure that your manufacturing facility has the correct approvals.

Compliance reviews and appeals

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

Taking the stress out of new substance applications

We can help you to bring a new ingredient for use in listed medicines to the Australian market in a way that meets your regulatory obligations. We can help you prepare safety and quality dossiers to meet the TGA's mandatory data requirements for new substances, helping you to determine if any extra testing or data is required. We can manage the evaluation process on your behalf and work with the TGA to obtain a successful outcome.

Have a listed assessed or registered complementary medicine? We're here to help!

Our experts are ready to help with preparing applications for listed assessed and registered complementary medicines. Our services include creating detailed technical dossiers, liaising with the TGA, and managing the entire lodgement process. Let us streamline your application journey, ensuring compliance and efficiency every step of the way.

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.