Biography

Danielle acts for large commercial clients in general litigation and contentious matters as well as pharmaceutical, medical device, cosmetics, food, automotive and general consumer goods companies in life sciences regulatory matters and commercial litigation.

Danielle advises on TGA registration and listings, compliance with mandatory and voluntary standards, import and export requirements and quarantine laws, advertising and labelling, product recalls and alerts, and health practitioner complaints. Her contentious practice covers product liability, therapeutics and medical device disputes, consumer law matters, coronial inquiries and regulatory compliance proceedings as well as general commercial and contract disputes. She engages regularly with the TGA, ACCC, AHPRA, HCCC, the Medical Council of NSW, Australian Border Force and other industry bodies.

Danielle acts across a broad range of industries within the life sciences and consumer goods sectors, managing regulatory compliance across multiple regulatory frameworks simultaneously. She advises clients on litigation strategies, mediations and informal settlement arrangements across contested product liability and regulatory matters.

Danielle brings specialist knowledge of the TGA regulatory framework alongside consumer law and product liability litigation capability. Her ability to advise across the full product lifecycle, from registration and compliance through to enforcement response and litigation, makes her particularly effective on matters where regulatory and legal risks intersect.

Credentials

Academic qualifications:

• Bachelor of Media / Bachelor of Laws (Macquarie University)

Danielle's experience

TGA regulatory compliance

Advises pharmaceutical, medical device and other health product clients on registration, listing, suspension and cancellation under the Therapeutic Goods Act, compliance with voluntary and mandatory standards, product recalls and alerts, and clinical trial requirements.

Product liability and consumer law

Advises and acts for companies in product liability, consumer law and therapeutics disputes, including mediations and formal proceedings.

Regulatory investigation response

Advises clients responding to investigations by the TGA, ACCC, AHPRA, the Medical Council of NSW and Australian Border Force, including strategy, privilege management and regulatory engagement.

Coronial inquiries

Advises clients in coronial inquiries involving therapeutic goods and medical devices.