Sponsoring your product approval across international markets
National regulations require that a local 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, New Zealand or NorthAmerica can be complex and time consuming.
We have the global knowledge and local experience of international biotech and pharmaceutical industries, and an expert understanding of the different regulations in each location.
Accelagen offers you the opportunity to accelerate clinical trial set-up by acting as a local sponsor and ensuring all regulatory obligationsare 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 national regulatory agencies and Therapeutic Goods Administration (TGA) / U.S. Food and Drug Administration (FDA)
- Assist with study insurance policies
How we work
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Marketing Authorisation Holder
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