Post-Clinical Trial Supply & Access in Australia
Supporting continuity of treatment when a trial ends, including extensions, roll-overs and transition into Managed Access Programs.
We provide end-to-end supply and regulatory support for clinical research in Australia and internationally, giving sponsors and CROs a single partner from trial start through post-trial and early-access supply.
HL Pharma acts as Importer of Record and logistics partner for post-trial and early-access medicines, coordinating importation, storage and national distribution on behalf of sponsors, CROs and hospital partners across Australia and the Asia Pacific region.
For sponsors managing active clinical trials, find out more about our APAC clinical and commercial depot and Importer of Record services.
Permit Support:
We coordinate biological import permits, controlled drug licences and related regulatory paperwork, in collaboration with sponsors and specialist regulatory partners where required.
Reverse Logistics Solutions:
We manage the return, reconciliation and destruction of unused clinical trial materials or medical devices, with full traceability and documentation for audits and close-out.
Post-Trial Drug Retention:
Secure, temperature-controlled storage of investigational products and associated records after study completion, aligned with sponsor requirements and TGA expectations.
Post-Trial Supply Management:
Ongoing importation, storage, distribution or pharmacy dispensing to support extension studies and continued patient access after the main trial period.
TGA Pathway Advice & Regulatory Guidance:
Practical guidance on appropriate TGA pathways for post-trial and early-access supply, including SAS and Authorised Prescriber routes, coordinated with your regulatory advisers.
TGA Reporting Coordination:
We support TGA reporting and safety coordination, working with trained pharmacists and specialist pharmacovigilance partners to fit within your global safety framework.
Central hub for Australia and the region
HL Pharma’s Melbourne facility provides validated, temperature-controlled storage and clinical logistics for investigational and post-trial medicines. Acting as a regional depot, we support:
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Australia, New Zealand and key Asia Pacific markets
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Controlled and non-controlled medicines, Schedules 2 to 9
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Short-term and long-term storage for studies, extensions and roll-over programs
Our team understands the operational pressures on clinical project managers, sites and depots and works to keep processes clear and manageable.
Facility Features & Quality Systems
Validated Temperature Monitoring
Continuous temperature mapping and real-time monitoring across our controlled environments, with 24/7 alerting.
Fully Alarmed Environment
Restricted-access zones with surveillance, alarms and monitored entry for high-value and controlled products.
Power Backup
On-site generator and documented contingency plans to help maintain conditions in the event of a mains power failure.
Flexible Pallet Storage
Storage options range from cartons to pallets, across both controlled and uncontrolled areas, to meet the specific needs of each study.
Batch Recall Readiness
Batch and expiry traceability via a validated Warehouse Management System (WMS), supporting compliant recalls and reconciliations.
Certified Operations
ISO 9001:2015 certified operations, aligned with Good Distribution Practice (GDP) and Good Wholesaling Practice (GWP).
Electronic QMS
An ISO 9001:2015 certified electronic Quality Management System (eQMS) providing document control, versioning, audit trails and secure electronic signatures in line with 21 CFR Part 11 and EU Annex 11 expectations.
Supporting Clinical Trials with Trusted Supply and Access
HL Pharma provides post-clinical trial supply and access in Australia through coordinated importation, storage, distribution and regulatory support. We work alongside your CROs, depots, regulatory consultants and safety partners, so patients can continue their therapy while you move towards registration or broader access.