Setting Up a Company In Australia: A BioPharma Success Story

A US-based biopharma company developing a new pregnancy drug needed to establish a local presence in Australia to progress their product through clinical trials. The company chose Australia for its world-class facilities, strong research reputation and robust regulatory framework. However, they faced several key challenges: establishing an appropriate legal and tax structure that complied with Australian requirements including the statutory requirement to appoint an Australian resident director; ensuring compliance with transfer pricing (TP) rules for dealings with the US parent company; and protecting intellectual property (IP) and managing R&D agreements to ensure eligibility for the Australian R&D Tax Incentive program to support clinical research funding.

David Conley, Partner at ECOVIS Clark Jacobs in Australia, was appointed as the resident director of the new subsidiary and used his local knowledge and networks to coordinate the specialist advisors the client needed. The solution involved:

- Incorporating the subsidiary and registering it with the Australian Tax Office (ATO)
- Referring a law firm experienced in R&D and IP to draft agreements
- Engaging a transfer pricing consultant to ensure compliance with Australia's TP rules
- Connecting the client with an R&D tax rebate consultant and managing communication between parties

This coordinated approach brought together the right tax, legal and regulatory advisors to enable the client to establish operations smoothly in Australia.

The client is now positioned to conduct multi-year clinical trials in Australia in full compliance with the Therapeutic Goods Administration (TGA). With the subsidiary established, governance in place and advisory networks coordinated, the company can focus on progressing its research. David Conley continues to serve as the resident director, providing continuity and oversight throughout the clinical trial program. The team also delivers ongoing accounting and advisory support to ensure the structure remains tax-efficient and compliant.