Advanced Wellness Regulatory Solutions are a team of highly skilled professionals who specialise in providing timely and reliable regulatory and research & development advice to the Complementary Medicines (CAM), Food and Cosmetics industries.
We have the expertise so you don’t have to learn the hard way.
Regulatory environments can be a minefield of legal jargon and grey areas. Our extensive experience in the Australian regulatory environment and good working relationships with the relevant governing bodies means that we are well positioned to assist you in navigating the terrain to take the stress out of any regulatory processes involving CAM, foods and cosmetics, saving you time and money on ‘expensive misunderstandings’.
In Australia, Complementary Medicines, such as herbal, vitamin, mineral and nutritional supplements, as well as sunscreens are classified as therapeutic goods and are included under listed medicines on the ARTG and as such, sponsors are required at the time of submitting an application, to certify that the medicine meets certain criteria for ingredients, dosage form, evidence, indications, side effects and warning statements.
Our experienced team of scientific researchers, naturopaths, marketing professionals and regulatory affairs consultants keep up to date with current research and market trends. Advanced Wellness Regulatory Solutions can assist with new product research and development, reformulations, liaison with contract manufacturers and suppliers of raw materials to facilitate the TGA process and a successful product launch.
In New Zealand complementary medicines are currently regulated under the Dietary Supplements Regulations 1985, which fall under the Food Act 1981. Dietary Supplements are presently regulated by Medsafe and therapeutic and marketing claims must comply with the guidelines set out by the Therapeutic Advertising Pre-vetting Services (TAPPS).
Foods are limited to the health claims that can be made in relation to specific ingredients and nutrients. We can assist you to formulate your products to maximise your claims. We can also assist you with development of your food to comply with the specific standards of the Foods Standards Code, including Formulated Supplementary Sports Foods, Infant Formula’s and Formulated Meal Replacements.
Training is fundamental to confidence and is particularly critical for highly complex and regulated markets. Advanced Wellness Regulatory Solutions recognises the crucial role of training in your understanding of the complex regulatory guidelines particularly in relation to Therapeutic goods and product compliance. To support your understanding of the involved and detailed area of regulatory affairs, Advanced Wellness Regulatory Solutions offers short courses.
Your first glance tool to assess the basic regulatory requirements of your ingredients or products, all in the one convenient place. Search individual resource bases for specific queries or the whole Resource Centre for more general enquiries.