TGA/Medsafe Medicine Applications
When you’re dealing with the Therapeutic Goods Administration (TGA), even having a crack regulatory team is no guarantee of success. Up to 20% of OTC applications alone are withdrawn or rejected.
Many more are delayed and suffer cost blowouts because they didn’t meet the TGA’s requirements. Without someone on your team who knows the system inside and out, you run a much higher risk of failing.
We know what the Therapeutic Goods Administration requires, – because we have worked there. Our collective experience is unmatched among pharmaceutical consultants.
Whether you want to register a new product, make a variation to an existing one, or switch a product from one classification to another – we can help you prepare the best possible application, and maximize your chances of a swift approval.