Pharmacovigilance Services for Local and International Companies

Supporting medicine and device safety in Australia

Pharmacovigilance is essential for keeping products on the market and protecting patients. HL Pharma helps pharmaceutical and medical device companies meet their TGA safety obligations without building a full in-country safety team.

Pharmacovigilance is available as part of our integrated service offering, not as a standalone service. For clients engaged across our regulatory, storage and distribution services, we combine dedicated drug and device safety expertise with our knowledge of Australian regulatory requirements, sponsor responsibilities, and supply chain operations, giving you one local point of coordination for adverse event reporting, TGA-compliant processes and day-to-day safety support.

Your Pharmacovigilance Support in Australia

Working with trusted pharmacovigilance specialists, HL Pharma serves as your local point of contact, helping you establish practical systems that align with your global safety framework and TGA expectations.

We can support:

Adverse event and product complaint intake via local channels
Safety case forwarding into your global PV system
Local literature monitoring and signal support
TGA-facing communications and inspection preparation

Our role is to ensure that Australian safety activities are organised, documented, and aligned with your global procedures.

What’s Included

Appointment and coordination of an Australian Pharmacovigilance Contact Person (A-PVCP)

Support for Qualified Person for Pharmacovigilance arrangements in Australia

Set-up and oversight of a TGA-compliant pharmacovigilance system in line with your global SOPs

Intake, triage and forwarding of adverse drug reactions (ADRs), device events and product complaints

Local literature checks and support for risk signal detection

Safety-related updates to the TGA, in coordination with your regulatory and safety teams.

Drug and Poison Schedule Australia TGA | HL Pharma

Scalable Pharmacovigilance Solutions

Our model is designed to scale with your portfolio and stage of growth.

Expert support from trusted specialists

We collaborate with established pharmacovigilance partners who bring experience from regulatory agencies and multinational life sciences companies, ensuring your safety system aligns with current expectations.

Flexible and cost-effective

You avoid the overhead of maintaining a dedicated in-country safety team. Support can be tailored to a single product, a launch portfolio or a broader marketed range.

Confidence in regulatory compliance

We support you through TGA pharmacovigilance inspections, audits and routine reporting, ensuring local processes remain consistent, documented and defensible.

Aligned with your commercial plans

By handling local safety operations alongside regulatory and distribution activities, we help free your team to focus on market access and product growth, while ensuring Australian PV obligations are met.

Quality, compliance and integration

Pharmacovigilance support from HL Pharma sits within a broader quality and logistics framework:

ISO 9001:2015 certified operations with an electronic Quality Management System (eQMS) for controlled documentation and audit trails
Aligned with Good Distribution Practice (GDP) and Good Wholesaling Practice (GWP)
Integrated with licensed, temperature-controlled storage and distribution from our Melbourne facility

This combination helps ensure that safety, quality and supply activities are connected rather than managed in isolation.

Why This Model Works for Your Australian Operations.

Local understanding of TGA pharmacovigilance expectations
Support for both pharmaceutical products and medical devices
Regulatory, storage and distribution capability combined with specialist PV expertise
Suitable for companies entering Australia or expanding existing portfolios
Clear, responsive communication with sponsors and global safety teams