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At our company, we provide comprehensive pharmacovigilance services to ensure the safety and efficacy of your medicinal products. Our team of experienced professionals is equipped to handle various aspects of pharmacovigilance, including screening of worldwide literature, signal detection, and submission of cases. Our services are available 24/7, and we offer a Qualified Person for Pharmacovigilance for round-the-clock support.
Partner with us for reliable and efficient pharmacovigilance services. Our experienced team ensures compliance with regulatory requirements, timely reporting of safety data, and comprehensive risk management for medicinal products. Contact us for more information on our pharmacovigilance services.
Screening of worldwide and local Dutch literature: Our team diligently monitors local and global literature to identify any potential safety concerns related to medicinal products. We conduct thorough literature screening, in alignment with your required lit-screening-strategy, to stay updated with the latest safety information.
Compiling of Risk Management Plans (Module 1.8.2): We assist in the development and compilation of Risk Management Plans (RMPs) in compliance with regulatory requirements. RMPs are essential for identifying and managing risks associated with medicinal products.
Compiling of periodic safety update reports (PSUR): We prepare periodic safety update reports (PSURs) in accordance with regulatory guidelines. PSURs provide comprehensive safety information and help in evaluating the benefit-risk profile of medicinal products.
Submission of cases: We handle the timely submission of individual case safety reports (ICSRs) to the relevant regulatory authorities. Our team ensures accurate and compliant submission of cases to meet regulatory requirements.
Signal detection: Our experts use advanced pharmacovigilance tools and techniques for signal detection, which involves identifying patterns or trends in safety data to identify potential safety concerns.
Handling of reports: We efficiently manage and process safety reports, including adverse drug reactions (ADRs), product quality complaints (PQCs), and medical inquiries. Our team ensures proper documentation and reporting of safety data as per regulatory requirements.
Pharmacovigilance training: We provide comprehensive training programs on pharmacovigilance, including pharmacovigilance regulations, case processing, signal detection, and risk management. Our training programs are tailored to meet the specific needs of our clients.
Compilation of Pharmacovigilance System Master File (PSMF): We assist in the compilation and maintenance of the Pharmacovigilance System Master File (PSMF), which is a comprehensive document that describes the pharmacovigilance system and its components.
Compilation of the summary of PV Master File (Module 1.8.1): We compile the summary of the Pharmacovigilance Master File (PV MF) as per regulatory requirements. The PV MF provides an overview of the pharmacovigilance system and its components.
Audits of pharmacovigilance systems: Our team conducts audits of pharmacovigilance systems to assess compliance with regulatory requirements and industry best practices. We provide recommendations and support for CAPA (Corrective and Preventive Actions) implementation as a result of audits and inspections.
Contact us today to learn more how we can support your company/products with our pharmacovigilance services.