At the heart of our commitment to patient safety lies a robust pharmacovigilance ecosystem – designed to support every phase of the product lifecycle. Whether you need an end-to-end solution or a region-specific service, our flexible model is built around your product portfolio and regulatory landscape.
Our services are delivered through strategically located offices in the UK and the Netherlands, supported by a global team of pharmacovigilance experts, offering a truly global reach with local expertise.
Whether launching a new molecule or maintaining post-marketing surveillance, we’re here to support you with scalable, compliant, and expert-led pharmacovigilance solutions.
With us pharmacovigilance isn’t just a regulatory requirement – it’s a strategic advantage
Our MICC provides round-the-clock support for healthcare professionals and patients, handling inquiries and adverse event reports with speed and accuracy.
Our team expertly manages complete lifecycle management of Individual Case Safety Reports including intake, triage, data entry, medical review, and submission.
We monitor global indexed and local literature sources to identify new safety data, reportable adverse events and emerging safety data and ensure timely reporting.
Our experts prepare Periodic Safety Update Reports (EU PSURs), US PADERs, Health Canada’s Annual Summary Reports, and more — customized to each market’s requirements.
We help you detect and assess emerging risks through proactive identification, evaluation, and reporting of emerging safety signals with documented risk mitigation strategies.
We develop EU and UK-specific Risk Management Plans tailored to national and regional health authorities expectations and therapeutic risk profiles.
Our team supports the full lifecycle of Risk Evaluation and Mitigation Strategies to align with FDA requirements to ensure safe drug usage.
Seamless support for electronic product submissions and data lifecycle management within EudraVigilance and related systems.
Through our CLINEVO Global Safety platform, we provide secure, validated, and scalable hosting solutions.
We ensure accuracy and integrity during safety database transitions with full data migration and quality control services.
We conduct pharmacovigilance audits globally and build fit-to-purpose Quality Management Systems for each Marketing Authorization Holder (MAH).
Our specialized team monitors evolving global pharmacovigilance regulations to inform your compliance strategies to stay ahead and compliant.
