There are often a number of ways to do the same job. We can work with you to ensure you obtain the optimum approval in the most time and cost-efficient manner for your OTC and prescription products.
The TGA process for applications based on a literature review rather than sponsor studies is a specific and very formal process. We have the experience to guide your product successfully through the process.
These are usually by far the most expensive and time-consuming parts of any development project. With our extensive experience in generic and other products we can review your bioequivalence or clinical strategy to ensure you gain approval for your products without unnecessary studies or expense.
We can provide individual on-site training to staff on pharmaceutical development and regulatory affairs.
Although many aspects are harmonised, TGA has a number of specific requirements that differ from other markets. We can make sure your data package meets all local up-to-date requirements.
We can take your application for prescription, OTC or complementary medicine from submission to approval, ensuring your product is approved to give the best commercial outcome.
Development of a product doesn’t finish with TGA approval. Let us help you to manage your products over their full life-cycle – we can assist with extensions of indication, line extensions and other variations to ensure you make the most of your products post-approval.
We can prepare responses to Agency questions, appeals under Section 60, as well as responses to TGA expert committees.