Expert advice on your individual regulatory needs against the specific and requirements and risk profile of your portfolio.
Whether you are at the beginning of your medtech journey or looking to expand or safeguard your existing portfolio, we can work with you as your principal regulatory consultant or as an extension of your regulatory team — accountable, technically rigorous, and direct.
For confidential consultation, contact the practice directly. Initial calls are without obligation.
Commercial in confidence communications, with your business and between regulators and manufacturers.
ARTG entries, registrations, and variations for medicines and medical devices. End-to-end management of submission strategy, dossier preparation, and TGA correspondence.
Medical device technical files, and quality overviews prepared to current TGA, MDR, FDA, Asian markets and ISO standards. Support with international submissions.
Statutory sponsor representation under the Therapeutic Goods Act for local and overseas manufacturers and distributors, including direct TGA interface.
Adverse event reporting, PSUR preparation, recall coordination, and audit support to maintain ongoing market authorisation including clinical data compliance and usability studies.
TGO 91/92, Essential Principle 13 labelling assessment, Therapeutic Goods Advertising Code review, and pre-publication review of consumer-facing material, training and conference interactions.
SOP development, GMP gap assessment, inspection readiness, manufacturing site clearance applications, Australian Manufacturer and Sponsor responsibilities, and merger and acquisition assistance.
Founded in Sydney in 2006, Glenn Street Enterprises has guided Australian and international sponsors through every significant reform of the Therapeutic Goods Act. The practice maintains a deliberately small client roster to preserve depth of engagement.
Our work is technically rigorous, professionally discreet, and built on long client relationships rather than volume. Each engagement is focused on the unique needs of the customer.
About the Practice →Glenn's reading of the Australian regulatory environment is unmatched. When we acquired an international device portfolio of significant complexity, his counsel resulted in the re-listing of twenty-three products without a single clarification request from the regulator.
Initial 30-minute consultations are complimentary. We will review your company’s needs, portfolio, and assess your next steps and requirements.