The registration and maintenance of pharmaceutical products or medical devices in Australia is a complex business, as the medical and healthcare sectors are amongst the most highly regulated and competitive industry sectors.
Our detailed understanding of the pharmaceutical business and the regulatory environment has made us the legal firm of choice for a significant number of the top 10 innovative pharmaceutical companies in Australia and for several Australian and US medical device companies.
Many of our team have science qualifications (including postgraduate qualifications) or pharmaceutical industry experience. This unique combination of in-house scientific, regulatory and legal expertise sets us apart from many other lawyers in this field, and our team's ability to immediately understand what are very often complex issues ultimately saves our clients time and reduces their costs.
We offer the full range of regulatory services, covering regulatory affairs, clinical research, medical affairs and health outcomes. Before and after market launch, we help clients with issues arising at any stage of the product management cycle, including research and development, registration and listing of drugs on the Australian Register of Therapeutic Goods, marketing approval, pricing, labelling, product launch and post-market compliance.
When you need administrative law remedies (for example, appealing against decisions of the Therapeutic Goods Administration refusing to register a new drug), you can rely on our significant experience in section 60 appeals and applications to the Administrative Appeals Tribunal.
