Our Drug Safety services support both local and international companies in meeting evolving safety reporting obligations under the TGA’s pharmacovigilance framework. Whether you require a fully outsourced solution or strategic oversight, we ensure the safety of your products is proactively managed throughout their lifecycle.
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. 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.
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