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Have you considered using a Literature Based submission (LBS) to extend the registration conditions of an existing product, change the Product Information details or even register a new medicine? The team at Mister Wolf Consulting (MWC) has extensive experience in developing and preparing LBS applications.  Our experience covers the provision of assistance to evaluate the …

It can be a little daunting, confusing, or even just time-consuming when your product doesn’t fit nice and neatly into a pre-defined box! For example, do you: wish to register a new medical device, however don’t have an EC Certificate? There may be other pathways to explore. have a product that looks like a medicine, …

While planning a clinical program it is valuable to consider the designations and determinations available through the Therapeutic Goods Administration (TGA). Where deemed appropriate, these pathways can help bring your product to market more quickly and with the potential for reduced costs. The team at Mister Wolf Consulting (MWC) has collectively more than 80 years’ …

Medicines in Australia are regulated by the Therapeutic Goods Administration (TGA).  The TGA has different pathways, data requirements, regulations and timelines for prescription medicines, over the counter medicines, and complimentary medicines. So how do I know my medicine type and what pathway should I use to include my medicine on the Australian Register of Therapeutic …