Navigating the path to regulatory approval and compliance
Our highly-experienced Regulatory, Quality and Compliance team have in-depth knowledge of the complexity of the regulatory environment in Australia and New Zealand. We help to position your products for the best possible outcomes by navigating the various challenges during the approval and life-cycle management process.
We will assist you in the development of effective submission strategies, ensure you are meeting your regulatory requirements, manage your submissions, and enhance your regulatory, quality and compliance activities.
Our consultants have expertise across prescription, over-the-counter (OTC) and complementary medicines, medical devices including in vitro diagnostics and software as a medical device, sunscreens, and cosmetics. We also have electronic publishing experts, who are adept at using a range of software solutions to enhance your regulatory, quality and compliance obligations.