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About Market Authorisation

National regulations require that an Australian or New Zealand entity is assigned a Marketing Authorisation Holder (MAH), or Sponsor, in order to have a therapeutic product registered without a local presence. For many of our international clients, establishing a formal entity in Australia can be complex and time consuming. Accelagen offers the opportunity to accelerate clinical trial set-up in the world’s fastest growing market by acting as a local sponsor and ensuring all regulatory obligations are fulfilled. We are here to support and maintain regulatory approval on your behalf to ensure a cost-effective and compliant outcome.

As your local sponsor, we can:

  • Execute all contracts and indemnities with sites and local vendors
  • Notify Australia’s regulatory Agency and Therapeutic Goods Administration
  • Assist with study insurance policies

Want to have a tangible impact on the future of human health together?