New medicine proposals
Even with a well-trained regulatory team, lodging an application for a new medicine or product is a huge task. No matter how effective the product is, all your hard work can be undone if vital data is missing or key questions are not answered.
That’s why expert advice is so important.
We know the regulations, the systems, and the people who manage them – because we have worked on both sides of the process. We know what to put in your proposal and what to leave out. We can anticipate problems and find ways to avoid them before they are raised by the TGA or Medsafe, when it can be too late to save your project.
This stage is key to your product’s success. You need to give the regulator every reason to say yes – and no reason to say no.
We have guided hundreds of products through the regulatory minefield. The fact is, the earlier we’re involved, the better your chances are of a good outcome – and the more money you’re likely to save.
Of course if your application is already in and has hit a hurdle, we can review the agency’s concerns and help you find the most effective way to address them.