Australian Sponsor / MAH
For many international clients, establishing a formal entity in Australia in order to remain the local Sponsor or Marketing Authorisation Holder (MAH) can be complex and time consuming. And when considering the regulatory and legal requirements imposed on the Sponsor in accordance with local legislation, this decision may become less attractive.
To directly address this, Accelagen offers our clients the option to act as the local Sponsor or Marketing Authorisation holder throughout the regulatory submission process and beyond, offering a cost-effective and compliant outcome. Accelagen will always apply this role with the interests of our clients first whilst ensuring all regulatory obligations are fulfilled. We have established internal policies and procedures that can be adapted to suit the projects or products requirements.