Regulatory Submissions

PharmOut's regulatory affairs consultants specialise in preparing submissions for the approval of products by the Australian Therapeutic Goods Administration (TGA), the Australian Government's regulatory body for therapeutic goods.

We can:

• Provide advice on registration strategies for medical devices, pharmaceuticals, complementary medicines, dietary supplements, IVDs and other therapeutic goods.
• Review the adequacy of data packages, prior to submission to the TGA
• Prepare clinical trial applications,
• Compile expert overviews and appeal TGA decisions on behalf of the applicant

To find out more

Contact us to discuss your project.