Viteia can provide advice, conduct a gap analysis and prepare and lodge applications and submissions for your medicine and medical device to the Australian regulator.

Our regulatory services include;

  • Application for listing or registration of medicines on the Australian Register of Therapeutic Goods.

  • Pre-screening of formulation and ingredients.

  • Application for conformity assessment for medical device manufacturers.

  • Application for inclusion of medical devices on the ARTG.

  • Application for a GMP licence of manufacturing facilities in Australia.

  • Assistance with GMP clearance for oversees facilities.