Secure optimal pharmacovigilance oversight with our EEA Qualified Person for Pharmacovigilance (QPPV) services. We offer a designated QPPV who brings extensive experience in European regulatory compliance.
Comprehensive PSMFs that detail your pharmacovigilance system’s process and responsibilities in accordance with regional and international regulations. Tailored SOPs provide clear guidance for every aspect of pharmacovigilance operations, ensuring consistency, compliance, and efficient decision-making.
We streamline the collection, processing, and reporting of adverse events in compliance with regional and international regulations. Our teams’ expertise ensures accurate ICSR documentation and timely submissions to regulatory authorities, maintaining patient safety as a priority.
Our expert team identifies potential signals, evaluates risks, and facilitates proactive measures. Integrating information from medical and scientific sources is a crucial element of ensuring patient safety. This extensive pool of information frequently forms a significant portion of the safety assessment for pharmaceutical products. Whether it offers valuable insights into potential adverse effects or illuminates various patient encounters, this body of literature plays a substantial role in enhancing our comprehension and management of the safety of medical products.
Our team employs advanced data analysis techniques to identify potential safety signals from large datasets. In pharmacovigilance, the process of signal detection and management requires continuous monitoring of individual case safety reports (ICSR) to pinpoint adverse event (AE) reports warranting further investigation. Traditionally, signals are identified using either qualitative or quantitative methods. Qualitative detection entails in-depth analysis through manual examination of individual or cumulative ICSR, while quantitative approaches employ statistical techniques like disproportionality analysis.
We gather, analyze, and format safety data to create comprehensive PSURs that meet international regulatory requirements. Our team ensures timely submissions to regulatory authorities, maintaining compliance with pharmacovigilance standards.
Our training programs cover essential regulatory frameworks, adverse event reporting, signal detection, risk assessment and more.
We assist in the development and negotiation of SDEAs to ensure a smooth exchange of safety information among involved parties.
The Extended EudraVigilance Medicinal Dictionary (XEVMPD) is the EMA’s current database for tracking pharmaceutical product data for drug safety monitoring and tracking. Compilation and submission of accurate product information to the EudraVigilance database, ensuring compliance with European Medicines Agency (EMA) guidelines.