An independent regulatory affairs practice, established 2006.

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 Street
Founder · Principal Consultant
Principal Consultant

Glenn Street

Glenn has spent more than three decades in Australian regulatory affairs — first in industry roles at major pharmaceutical and medical device sponsors, and since 2006 in independent practice.

His work has encompassed ARTG entries for first-in-class biologics, technical file remediation for medical device portfolios, and recall coordination for high-volume consumer health products. He has appeared in industry consultations on three significant TGA reforms.

Clients engage Glenn directly. There is no junior team and no account management layer — every matter is led by the principal.

Practice History

Twenty years of continuous regulatory practice.

Selected milestones from the firm's history.

2006

Practice founded in Glebe, Sydney

Glenn Street Enterprises opens with three foundation clients across complementary medicines and Class II devices.

2010

First multinational device portfolio engagement

Engaged as Australian sponsor of record for a US-listed device manufacturer with twelve ARTG entries.

2014

Listed Medicines Notification reform

Guided complementary medicine clients through the transition to the new permitted indications framework.

2017

Medical device reclassification reforms

Supported clients through the up-classification of spinal implants and other reclassification waves.

2021

IVD and software-as-a-medical-device practice

Established practice in SaMD classification and digital health regulatory pathways.

2026

Twentieth anniversary of independent practice

The practice serves 150+ active clients across pharmaceuticals, devices, biologicals, and complementary medicines.

Engage The Practice

Confidential consultation, without obligation.

Initial 30-minute consultations are complimentary. We will review your portfolio, classification matters, and provide a written quote within two business days.

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