Years of Regulatory experience is not the same as as TGA appeal experience. Enimera RegsPlus has the experience.
The first step in appealing a TGA decision is understanding if that TGA decision an be appealed. The second step is to decide whether appealing that TGA decision is the right decision for your organisation.
Assuming the answer to both questions is YES, then preparing to appeal a TGA decision can begin.
In fact, should your Regulatory Strategy already have identified a significant risk, or if the TGA evaluation has raised a new risk, it is helpful to explore ‘what if…’ scenarios in the event of an unfavourable TGA decision. Our on-line TGA appeals overview training module is a great way to learn the basics.
We have the right experience to lead, guide or support your TGA appeal considerations, preparations, or submission. We work closely with your legal function, or with our Legal partner if you prefer, to ensure your appeal presents Regulatory and legal matters appropriately.
Contact Enimera RegsPlus to understand how we can support your TGA appeal activity.
Refer to our blog for an overview of the TGA appeal process.