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