What We Do

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End-to-end regulatory support within Australia and globally — including regulatory strategy, preparation for and representation at meetings with regulators including TGA, FDA, EMA and MHRA, and writing/review of documents such as clinical trial protocols, Investigator's Brochures, INDs, and IMPDs, and regulatory submissions.

Strategic clinical development support, especially for translational and early-phase trials - including trial design, and selection of sites, CROs and other service providers.

Board-level counsel for biotech companies navigating growth, fundraising, or regulatory scrutiny — including acting as an Australian resident director for overseas entities requiring local board representation.

Scientific, regulatory, and clinical due diligence for investors, acquirers, and boards evaluating biotech and pharma opportunities.

Extensive experience with cell-based therapies, as well as monoclonal antibodies and small molecules. Therapeutic area experience spans immunological, haematological, cardiovascular, musculoskeletal, and metabolic disorders.