REGULATORY AFFAIRS CONSULTANTS
EXPERTS WITH EXPERIENCE AS REGULATORS
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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 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.
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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.
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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.