TGA Regulatory Filings

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We manage the full lifecycle of Therapeutic Goods Administration (TGA) submissions, including preparation, lodgment and ongoing regulatory correspondence. This ensures your medicines, medical devices, or biologicals meet all Australian regulatory requirements for lawful supply and market entry.

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Medical Device Registrations & Listings

 

We support the correct classification, documentation, and inclusion of medical devices on the Australian Register of Therapeutic Goods (ARTG). Our process ensures each device meets the applicable regulatory standards, conformity assessment requirements, and post‑market obligations.

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Prosthesis Listing Preparation

 

We prepare and coordinate submissions for the Prostheses List, ensuring compliance with Department of Health requirements. This includes evidence collation, pricing justification, and alignment with clinical use to support successful listing and reimbursement pathways.