Pharmacovigilance

We provide pharmacovigilance system maintenance services tailored to small and medium-sized Marketing Authorisation Holders, biotech companies, and pharmaceutical companies. Our scalable PV solutions support continuous compliance with EU GVP requirements and help ensure that pharmacovigilance processes remain efficient, inspection-ready, and aligned with regulatory expectations. As part of this service, we support signal management and safety monitoring processes, provide oversight of outsourced pharmacovigilance activities, assist with the translation and local implementation of additional Risk Minimisation Measures, and help maintain compliant PV procedures and systems according to applicable regulatory requirements.

Effective adverse event management is essential for maintaining pharmacovigilance compliance and protecting patient safety. We provide comprehensive adverse event management services in accordance with EU GVP, ICH guidelines, and applicable regulatory requirements. A functional adverse event management system is a critical priority for every Marketing Authorisation Holder, as effective ICSR management supports accurate case handling, follow-up, documentation, medical assessment, quality control, and timely reporting. Our processes help reduce compliance risks, support inspection readiness, and minimise the risk of critical findings during audits and regulatory inspections.

Our Regulatory Intelligence services help pharmaceutical companies stay informed about changes in pharmacovigilance legislation, guidelines, and regulatory expectations. We continuously monitor publicly available regulatory sources, including EMA, national competent authorities, ICH, EU GVP updates, regulatory legislation, and other relevant sources. Based on this monitoring, we provide regulatory updates and summaries tailored to client portfolios, assess the impact of regulatory changes on pharmacovigilance systems and processes, support the implementation of new or revised regulatory requirements, and communicate relevant regulatory changes to stakeholders in a clear and practical way.

Marketing Authorisation Holders are required to perform regular medical literature monitoring in accordance with applicable legislation and GVP guidelines. We provide local medical literature monitoring services to support the timely identification and assessment of safety information. Our service includes weekly local literature screening, text review, evaluation of relevant safety information, identification of potentially reportable adverse events, follow-up with article authors where required, and documentation support to help maintain pharmacovigilance compliance.

We provide tailored pharmacovigilance training services designed to increase employee awareness and support compliance with EU GVP and applicable regulatory requirements. Our trainings help ensure that employees involved in safety-relevant activities understand their pharmacovigilance responsibilities and know how to identify, report, and manage safety information correctly. The training scope may include PV awareness training for non-PV employees, role-based pharmacovigilance training for PV-relevant functions, training on adverse event identification and reporting, introduction to ICSR processes and reporting timelines, and product-specific pharmacovigilance training.

We support pharmaceutical companies and Marketing Authorisation Holders with the preparation, translation, implementation, submission, and local management of Risk Minimisation Measures required by National Competent Authorities. Our services help ensure that both routine and additional risk minimisation activities are implemented correctly to support the safe and effective use of medicinal products. Risk Minimisation Measures are generally divided into routine RMMs, which apply to all medicinal products as part of standard product information, and additional RMMs, which are product-specific measures required to further reduce identified risks. Our aRMM support may include the management of materials such as patient alert cards and DHPCs, translation of all aRMM documents, local implementation, submission to national authorities, and communication with competent authorities regarding aRMM requirements.