Registering prescription medicines

PharmOut on supplies support for Australian TGA Drug Registration – Prescription Medicines undergo the highest level of regulation of all the medicines regulated by the Therapeutic Goods Administration (TGA) for supply in the Australian market.

PharmOut consultants are experienced in the TGA’s requirements for the registration of prescription medicines and apply their knowledge and experience to provide fit-for-purpose solutions across the life-cycle of products.

PharmOut can help you with:

  • regulatory strategy for prescription medicines
  • technical writing and preparation of the Common Technical Document (CTD)
  • product development: regulatory compliance
  • clinical trials: documentation requirements, preparation and submission of the application to the TGA
  • Registration of prescription medicines: requirements, gap analysis, preparation and submission of the application to the TGA
  • post-registration compliance

For further information, read our regulatory white papers, or Contact us.