Danielle Kuti is a therapeutic and consumer goods regulatory compliance lawyer and litigator. Danielle advises on a broad range of commercial litigation and regulatory matters, with particular expertise in the life sciences and consumer goods sectors. She acts for pharmaceutical, medical device, cosmetics, food, automotive and consumer goods companies on regulatory compliance, product liability, consumer law, commercial disputes and regulatory investigations.
Danielle represents major commercial clients in complex litigation and contentious regulatory matters. She has extensive experience advising pharmaceutical, medical device, cosmetics, food, automotive and consumer goods companies on regulatory obligations and dispute resolution.
Her regulatory practice includes advising on Therapeutic Goods Administration (TGA) registrations and listings, product classification, compliance with mandatory and voluntary standards, import and export requirements, biosecurity and quarantine laws, advertising and labelling, product recalls, safety alerts and health practitioner complaints. She regularly engages with regulators including the TGA, ACCC, AHPRA, the Health Care Complaints Commission (HCCC), the Medical Council of NSW, Australian Border Force and other government agencies.
Danielle’s contentious and disputes practice encompasses product liability claims, therapeutic goods and medical device disputes, consumer law proceedings, regulatory enforcement actions, coronial inquests, commercial and contractual disputes, and investigations. She works closely with clients to develop practical litigation and regulatory strategies, guiding them through mediations, negotiated resolutions and court proceedings where required.
Drawing on her specialist knowledge of the Australian regulatory framework for therapeutic goods, together with extensive experience in consumer law and commercial litigation, Danielle provides strategic advice across the entire product lifecycle—from product development, registration and market entry through to ongoing compliance, enforcement responses and litigation. Danielle works closely with her clients to enable them to effectively manage legal, regulatory and commercial risk in highly regulated industries.
