Pricing & policy decisions: Do you have an external or company only view?
The effectiveness of one intervention compared to another, also known as the treatment effect, is frequently a key consideration when assessing the cost-effectiveness of alternative therapeutic interventions for economic…
We really do pride ourselves on efficiency and quality. We aim to respond and provide quality information in a timely manner, as we understand the urgency of these enquiries and…
The need for Medical Information services outside the standard 9am to 5pm AEST business day has become increasingly important and is required by sponsors nationally and globally. With having extended…
In recent years public expectations for rapid identification and the prompt management of emerging safety issues has grown exponentially, with drug safety coming to the forefront of many consumers’…
Using Overseas Approvals for Medical Devices to Enter the Australian Market
In May 2017, the TGA issued a public consultation to seek feedback on the proposed use of marketing approval by comparable overseas regulators for devices manufactured overseas, to support inclusion…
Navigating challenges throughout the lifecycle maintenance process can be complex.
A regulatory agency expectation for the sponsor following the registration of a therapeutic good in Australia or New Zealand is keeping the licence up to date. This is undertaken through…
Prior to submitting a new medicine for registration or listing, TGA require the sponsor to have already submitted GMP Clearance applications for overseas sites involved in the manufacture of the…