Our Drug Safety services assist local and international companies in achieving drug safety compliance while navigating the evolving safety reporting obligations under the TGA’s pharmacovigilance framework. Whether you need a fully outsourced solution or strategic oversight, we ensure proactive management of your products' safety throughout their lifecycle.
We specialise in establishing and maintaining pharmacovigilance systems that align with both Australian and international regulatory requirements.
Our services include literature monitoring and signal detection to support the early identification of emerging risks, as well as the preparation and submission of safety reports such as AERs, PSURs, and RMPs.
We also provide local Australian pharmacovigilance contact person (A-PVCP) services to ensure in-market compliance and serve as a single point of contact for regulatory authorities.
Additionally, we offer audit support and CAPA implementation for internal reviews or authority inspections, along with training and process development to embed pharmacovigilance knowledge across your organisation.
Moreover, we sell ready-to-deploy, out-of-the-box SOP packages comprising cross-linked, field-tested documents refined over the years to ensure consistency and reliability. Each SOP adheres to Good Documentation Practice and complies with Australian pharmacovigilance (PV) requirements, allowing companies to implement them with minimal modifications for near-instant compliance, streamlined training, and auditable traceability across processes.
We combine scientific rigour with practical experience in safety monitoring. With backgrounds in pharmacology, biochemistry, and behavioural science, we bring a multidisciplinary perspective to safety case evaluation, signal detection, and stakeholder communication. Our strategic insights allow us to tailor systems that not only meet regulatory obligations but also integrate seamlessly with your internal processes. Whether managing day-to-day safety operations or supporting inspections, we act as a trusted extension of your business, responsive, and fully aligned with your goals.
We partnered with an international biotech company to integrate local medical information and pharmacovigilance systems for their Australian launch. Working within their global safety structure, we developed a joint triage model for adverse event and inquiry handling, ensuring seamless escalation and response met their safety reporting obligations. By aligning our reporting with their internal systems and offering local literature screening, we helped reduce duplication and enabled audit-ready compliance. The model was praised for its scalability, enabling fast onboarding of additional products.
Copyright © 2026 Hilaxon Pty. Ltd. - All Rights Reserved
Homepage images by @chrissyngphotography
Hilaxon would like to use cookies and other technologies to better understand your use of our website. This enables us to improve your future experience on our website.
Information collected from cookies are de-identified, anonymous and do not contain sensitive personal information. We use this information to analyse our Website’s performance. Further details can be found in our Privacy Policy.
If you Decline, click outside the box, or otherwise close the box, then data won’t be tracked. Tracking tools will only be loaded if you Accept.