FIRB approvals, subsidiary formation, and the Australian regulatory pathways for United States companies entering the market.
Opportuna Legal advises on the Australian side of inbound market entry, particularly in life sciences and defence. Engagements cover Foreign Investment Review Board clearances, Australian subsidiary formation, and the regulatory and contractual steps that follow. The firm works alongside United States counsel on the United States elements of cross-border transactions.
Foreign Investment Review Board notifications, exemption analysis, pre-engagement strategy, and negotiation of conditions for United States-headquartered acquirers and investors.
Standing up an Australian entity: company formation, director appointments, registered office, ASIC registration, tax registrations, and the operating arrangements that follow.
TGA registration and the adoption of international standards including ICH E6(R3), clinical trial structures, sponsor obligations, R&D Tax Incentive considerations, and market access strategy.
ASDEFCON contracting, AUKUS-adjacent compliance, and teaming arrangements with Australian primes.
The 2026-27 Federal Budget confirmed substantial investment in Australia's clinical trials infrastructure. For international sponsors, three measures are particularly relevant: continued NOSS funding, stepped-up MRFF disbursements, and continued PrOSPeCT support.
Read article →Australia's Research and Development Tax Incentive is one of the most generous programs of its kind globally and plays a significant role in making Australia an attractive destination for clinical research.
Read article →The TGA has finalised its Australian-specific annotations to the ICH E6(R3) guideline for Good Clinical Practice following public consultation. The outcomes were finalised on 16 December 2025, delivering a clear framework for clinical trials conducted in Australia.
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