TGA Sponsorship & Medical Device Registration Services
TGA market access and compliance support for Australia and the broader Asia Pacific region.
Whether you are an Australian based manufacturer launching a therapeutic product or an international company expanding into the Australian healthcare market, HL Pharma provides end to end support for TGA sponsorship, regulatory submissions and post market compliance, aligned with your clinical, logistics and commercial plans.
We act as an Australian sponsor for overseas manufacturers and, for many projects, can also act as Importer of Record into Australia, coordinating regulatory, import and depot activities from our Melbourne facility. We manage TGA submissions and ongoing sponsor obligations with audit ready, traceable records controlled within an ISO 9001:2015 electronic quality management system, aligned to 21 CFR Part 11 and EU Annex 11 expectations.
What is an Australian TGA Sponsor?
If you’re looking to supply medicines, medical devices, complementary medicines, or biologicals in Australia, the Therapeutic Goods Administration (TGA) requires your product to be sponsored by an Australian based entity. If you’re not based in Australia, or don’t want the risk or resourcing involved in handling sponsorship in-house, HL Pharma can act as your trusted third party sponsor.
Key Sponsor Responsibilities
Submitting and managing TGA applications, including ARTG inclusions
Liaising between your organisation and the TGA
Maintaining regulatory and compliance records
Coordinating adverse event reporting and pharmacovigilance activities
Updating the TGA on relevant product and company changes
Your Partner in Australian Product Registration
HL Pharma supports a wide range of clients: Australian companies creating or importing a product for the first time; overseas pharmaceutical and medical device manufacturers seeking market access; contract manufacturers and CROs seeking a reliable local sponsor; and healthcare start-ups or compounders entering regulated categories.
TGA Registration and ARTG Inclusion
We prepare and submit registration and listing dossiers, coordinate supporting data and correspondence, and help ensure your products meet Australian regulatory requirements for ARTG inclusion.
Independent Sponsorship
As an independent sponsor, HL Pharma separates regulatory sponsorship from your commercial arrangements. You retain control over your registrations while we manage the local sponsor role, reporting and record-keeping.
Regulatory Compliance and Ongoing Support
Once your products are on the ARTG, we manage routine sponsor obligations, including safety updates, variations, recalls, and regulatory notifications, so you can maintain compliance throughout the product lifecycle.
Pharmacovigilance Services
Through specialist pharmacovigilance partners, HL Pharma can support the intake of safety cases, adverse event reporting, and safety data management for medicines and medical devices, aligning with TGA expectations and your global safety procedures.
Why Choose HL Pharma?
- Experience across medicines, medical devices, complementary and OTC products
- Structured to support both Australian and international companies
- Independent sponsor model that preserves your commercial flexibility
- A team with strong regulatory understanding and a dedicated compliance focus
- Integrated with licensed, temperature-controlled storage and distribution in Melbourne
- ISO 9001:2015 certified, operating under GDP and GWP with an ISO 9001:2015 certified eQMS
Get started today
Whether you are entering the Australian market for the first time or adding a new product to your portfolio, HL Pharma can simplify the regulatory path and connect sponsorship with storage and distribution.