New medicine proposals

Even with a highly qualified and experienced regulatory affairs team, issues will inevitably be raised by the agency during evaluation. Some problems will be difficult to address and cause delays or lead to the application being rejected. Many of these problems can be avoided by getting the right advice before the application is lodged.

We can help at the concept stage by giving you feedback on proposed applications and at a later stage by reviewing your application before it is submitted to the agency. We can save you time and money by anticipating problems and suggesting ways to avoid them.

If the application has already been lodged and you are experiencing problems or facing a rejection we can help by reviewing the application and the agency’s concerns to help you find the most effective way of addressing those concerns and having your application approved.

We know the regulations, the systems and the people well – so we can help you get your application right the first time with a minimum of fuss. We understand the need for absolute confidentiality and guarantee to maintain it at all stages.

Contact us for more information.



Next : New product applications to the TGA or Medsafe