A global provider of development and commercialisation services to the pharmaceutical, biotechnology and medical device industries.
The long-awaited transition to the EU Medical Devices Regulation (MDR) is looming. The regulatory realm of medical devices is in a state of flux and poised on the brink of the most significant change to the landscape in decades. Despite the postponement of the EU Medical Devices Regulation’s implementation to May 2021 appearing to offer …
EU MDR: Are ROW Device Sponsors Ready for the Ripple Effect?Read More
Australian science and technology sectors are talking about a ‘research revival’ as the Federal Government splashes the cash in the 2020 Budget. 2020 Budget Cash Splash Thanks to COVID-19, early October saw the first Australian federal budget delivered in a recession in 30 years. The Treasurer said personal income tax cuts, infrastructure spending, and business …
Australian Government Cash Splash on High Tech RecoveryRead More
By now, we should all be very familiar with the new Form for providing Product Information (PI) for Australia. Each time you make a change to a PI, be it safety-related or otherwise, you’re required to provide the updated PI to TGA in the new format. The looming deadline for marketed product PIs to be …
The Pointy End of the PI Reformatting Transition PeriodRead More
We may have a global market but do we really consider options outside of USA and EU when developing our Therapeutic Product Commercialization strategy? The USA, EU/UK are large markets with clear regulatory requirements, so they are often first targets for therapeutic product commercialization, either for medicines or medical devices. A New Perspective But what …
Since 2015, Medsafe NZ, the New Zealand Medicines and Medical Devices Safety Authority, has been working on a new therapeutic products regulatory regime to replace and modernise the regulatory arrangements for medicines, and provide regulation of all therapeutic products. Whilst we are still waiting for the progression of the Therapeutic Products Bill through parliament, the …
This is a very exciting day for me, a Kiwi living and working in Australia. Today, we officially launched our New Zealand entity Adjutor Healthcare (NZ) Limited. The mission of Adjutor Healthcare (NZ) Limited, and parent company Adjutor Healthcare Pty Ltd is three-fold. Firstly, we want to help bring international business to the Australia/New Zealand …
