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国家法规要求为当地实体分配上市许可持有者（MAH）或赞助商，以便在没有当地存在的情况下注册治疗产品。
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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营销许可持有人
case studies
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