Mister Wolf Consulting

Mister Wolf Consulting is an Australian-based regulatory affairs and quality assurance consultancy specializing in therapeutic goods including prescription pharmaceuticals, biologics, medical devices (including diagnostics/software), complementary medicines, cosmetics, disinfectants and food. The team has extensive experience supporting literature-based submissions to the TGA and other regulatory bodies. They provide services such as product reviews, risk management plans (RMPs), scientific justifications for registration changes or new registrations—often working with both clinical/non-clinical experts to compile submissions that meet complex requirements of the Australian healthcare system.