A global provider of development and commercialisation services to the pharmaceutical, biotechnology and medical device industries.
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 …
The appearance of misleading terms and claims on websites and social media has attracted the attention of the TGA. The Therapeutic Goods Administration in Australia (TGA) has advised that fines were imposed via the Federal Court for misleading advertising by Peptide Clinics Australia (Peptide Clinics Pty Ltd), to the tune of $10 million (for breaches …
Consumer Insecurity / Vanity Targeted by TGA – Massive FinesRead More
Today, we are pleased to introduce one of our affiliates and guest blogger, Anna Pannuzzo from WorkPlacePLUS. In this post, Anna discusses some key workplace health, safety and other legal aspects of setting up or maintaining a sales office in Australia. Expanding your business can be an exciting time, but setting up abroad comes with …
