Founded in Sydney by Glenn Street, the practice has served Australian and international sponsors through every significant TGA reform of the past two decades.
Glenn has spent more than three decades in Australian regulatory affairs — first at the TGA, and since 2006 in independent practice.
With more than 20 years’ experience in the health sector, and over 17 years in the medical device regulatory and quality arena, Melanie brings a passion for the delivery of safe, innovative and effective healthcare. Having worked across a wide range of clinical fields, she applies that knowledge to suit the needs of varied clients and employers.
She has expertise in Class III device applications and associated level 2 audits (including devices with medicinal components and AIMDs), clinical literature reviews, marketing and consumer literature, and advice on regulatory requirements for companies in line with industry standards. She understands international regulations and has worked on the implementation of the transition from the EU MDD to MDR.
Melanie also submits prostheses list applications and assists with reimbursement coding to maximise market access and returns. She is a BSI ISO 13485 accredited internal auditor. Her risk management, project planning, and interpersonal skills help companies with the compliant and timely release of their products and growth in both the Australian and international healthcare markets.
Languages: English and German.
Initial 30-minute consultations are complimentary. We will review your company’s needs, portfolio, and assess your next steps and requirements.