Mandi is a general commercial litigator, including defending clients in civil penalty proceedings brought by regulators. She also specialises in therapeutic good regulation, product liability and consumer law including foods and beverages.

Biography

Mandi acts for local and international pharmaceutical, biotech, medical device, medicinal cannabis and consumer goods companies across the life sciences, food and beverage, cosmetics, electronics and automotive industries.

Mandi advises on TGA registration and licensing, suspension and cancellation proceedings, section 60 reviews, clinical trials, pricing and reimbursement, product defects and recalls, advertising and labelling, and compliance with Australian and international standards. Her litigation practice covers product liability, class actions, white-collar crime, contractual disputes, TGA and ACCC investigations and prosecutions, including defending civil penalty proceedings, coronial inquiries and privacy law. She also advises on data breach management and privacy obligations.

Mandi has extensive experience in the Federal Court (including class actions), coronial inquests, the Healthcare Complaints Commission, and matters involving the Australian Border Force and clinical research organisations. Mandi has extensive experience in the Federal Court (including class actions), coronial inquests, the Healthcare Complaints Commission, and matters involving the Australian Border Force and clinical research organisations.

Mandi is especially well-regarded for her knowledge of complex regulatory regimes , which she interprets for pharmaceutical, medical device and other industry clients. Her practice spans both front-end regulatory advisory and contentious proceedings, allowing integrated advice from product registration through to litigation and enforcement.

Credentials

Academic qualifications:

Mandi's experience

Coronial inquiries

Mandi has acted for clients in two coronial inquiries involving medicines and medical devices.

Section 60 Internal Reviews under the Therapeutic Goods Act

Mandi regularly advises and assists her clients in section 60 internal reviews where the TGA has cancelled or suspended therapeutic goods.  This work often leads to acting for clients in the Administrative Review Tribunal.

ACCC investigations and prosecutions

Mandi represents companies investigated and prosecuted by the ACCC and State bodies across pharmaceutical, consumer goods, food and beverage, cosmetics and automotive industries.

Product liability matters

Mandi provides advice to clients and defends them in product liability matters and claims. Her work also involves assisting clients in ACCC initiated investigations and prosecutions.

Therapeutic good recalls and consumer good recalls/ withdrawals

Mandi acts for manufacturers and suppliers of medical devices, cosmetics and consumer goods including foods and beverages in relation to recalls and withdrawals. She also assists her clients interpret and apply Australian and international standards.

Privacy and data breach management

Mandi advises companies on their obligations and responsibilities under Australia’s privacy regime. She provides advice and management of real and suspected data breaches, including reporting to Commonwealth and State regulators.

Awards, recognition and ranking