End-to-End Regulatory Support for TGA Market Entry in Australia
HL Pharma provides pharmaceutical services that support clinical trials, managed and early‑access programs, commercial supply, and critical-medicines across Australia and the wider Asia‑Pacific region, including global drug sourcing under TGA frameworks.
Our Melbourne facility provides advanced temperature‑controlled storage and cold‑chain logistics for commercial, clinical and investigational medicines, and holds an Office of Drug Control (ODC) import and export licence for narcotic and psychotropic substances.
HL Pharma holds ISO 9001:2015 certification and offers secure, compliant storage and distribution for Australian clinical trials and commercial medicines, including controlled substances under Schedules 2, 3, 4, 8, and 9, unregistered pharmaceuticals, and speciality products.
Pharmaceutical and Medical Device Registration & Sponsorship
We assist domestic and international companies in registering and sponsoring products through the Therapeutic Goods Administration (TGA). HL Pharma coordinates regulatory strategy, dossier preparation, submission and ongoing sponsor obligations to support efficient, risk-managed market entry in Australia.
Post-Clinical Trial Supply & Managed Access Programs
We support ongoing access to investigational or unapproved treatments after trials conclude, ensuring that workflows remain practical for prescribers. HL Pharma facilitates supply under the TGA Special Access Scheme (SAS), Managed Access Programs (MAPs), and Authorised Prescriber (AP) pathways, and manages import or local supply, temperature-controlled distribution, and documentation so that patients can remain on therapy during the transition to full registration.
Pharmacovigilance & Regulatory Safety Services
Through our pharmacovigilance partners, HL Pharma provides safety oversight, including adverse event handling, safety data management and risk mitigation planning. We help sponsors meet TGA post-market requirements and maintain patient safety across the product lifecycle.
Medical Supply for Critical and Unmet Needs
HL Pharma sources and distributes medicines under the TGA’s special provisions, including SAS, AP, and Section 19A exemptions. We act quickly to support the supply of unapproved medicines during shortages or urgent clinical needs, helping maintain continuity of care for patients in Australia.
Scalable Storage & Distribution Solutions & Supply Chain Support
HL Pharma links regulatory and safety services with compliant, validated temperature-controlled storage and distribution, ensuring products are consistently managed from approval through to delivery. Whether you are entering the Australian market or scaling existing operations, we can support your supply chain with a single, coordinated team.
Need support with pharmaceutical storage, cold-chain distribution, global medicine sourcing, regulatory support or Australian sponsorship? Leave us a few details, and our team will be in touch within 1 business day.