APAC Clinical & Commercial Depot and Importer of Record

APAC Clinical trial and early access hub

International sponsors and contract research organisations utilise HL Pharma as their local depot and Importer of Record for clinical trial supplies and early-access programs in Australia and across the wider Asia-Pacific region. Services include temperature‑controlled storage for investigational products, including Schedule 8 and Schedule 9 controlled medicines, pick‑and‑pack to trial sites and hospitals, integrated reverse logistics for returns, reconciliation and destruction of unused materials, and support for blinded and complex study designs. When trials conclude, HL Pharma provides post‑trial supply solutions so eligible patients can continue therapy under approved access schemes.

For sponsors requiring continued supply after trial completion, find out more about our post-trial supply and early access services.

Small-batch and early-phase clinical trial distribution

HL Pharma provides small-batch clinical trial distribution for sponsors and CROs managing early-phase, named-patient and limited-volume studies in Australia.  Operating without minimum volume requirements, our Melbourne depot supports carton and unit-level picking, site replenishmet and named-patient dispatch within a GDP-aligned quality system.  For international sponsors seeking a compliant Australian depot for a small or complex trial, we offer Importer of Record services, temperature-controlled storage and national distribution within a single, accountable framework.

Commercial medicines and outsourced logistics

For launched products, HL Pharma acts as an outsourced pharmaceutical logistics provider and Importer of Record, managing receipt, storage, inventory control, quarantine and order fulfilment from the Melbourne depot. Operations are supported by a warehouse management system and a client portal that provides 24/7 real‑time visibility of all inbound and outbound stock movements.

Temperature-controlled, secure storage

The Melbourne facility provides GWP and GDP‑aligned, temperature‑controlled storage across ambient, cold‑chain, frozen and ultra‑low ranges, with secure areas for controlled drugs and other speciality products. Validated temperature mapping, continuous monitoring and alarm systems are supported by electronic records compliant with 21 CFR Part 11 and EU GMP Annex 11, ensuring tamper‑evident audit trails and maintaining product integrity from receipt through to dispatch.

Quality, licensing and oversight

HL Pharma operates under TGA and state licences for the storage and distribution of scheduled and unregistered medicines and is certified to ISO 9001:2015 by BSI (Certificate FS819588). An electronic quality management system aligned with this standard and incorporating validated temperature monitoring compliant with 21 CFR Part 11 and EU GMP Annex 11 supports inspection‑ready operations, structured documentation and clear traceability for client audits and regulatory reviews. This gives clients a quality‑led, audit‑ready depot partner with stronger governance, traceability and operational oversight than a generic warehouse provider.

For further detail on our quality, regulatory and governance framework, please see our dedicated overview.