Our Drug Safety services assist local and international companies in achieving drug safety compliance while effectively 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 comprehensive pharmacovigilance systems that align with both Australian and international regulatory requirements, ensuring robust biologicals, device and drug safety compliance.
Our services include literature monitoring and signal detection to support the early identification of emerging risks, as well as the meticulous preparation and submission of safety reports, including 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 rigor with practical experience in safety monitoring for biovigilance, device safety and drug safety compliance. With backgrounds in pharmacology, biochemistry, and behavioral science, we bring a multidisciplinary perspective to safety case evaluation, literature monitoring, signal detection, and stakeholder communication within a robust pharmacovigilance framework. Our strategic insights allow us to tailor systems that not only meet TGA regulatory obligations for safety reporting 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 product launch. Working within their global pharmacovigilance framework, we developed a joint triage model for adverse event and medical enquiry handling, ensuring seamless escalation and response that 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 drug safety compliance. The model was praised for its scalability, enabling fast onboarding of additional products.
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