Evidence-based pharmacovigilance services supporting signal evaluation, benefit–risk assessment and post-market safety throughout the product lifecycle.
Request a ConsultationPharmacovigilance plays a critical role in protecting public health by continuously monitoring the safety of medicinal products after they enter clinical use. The analysis of real-world safety data, scientific literature and emerging safety signals provides essential evidence for identifying potential risks and supporting informed regulatory decisions.
At TOXENTRA, we provide independent scientific pharmacovigilance support based on evidence-driven methodologies and current regulatory expectations. Our expertise combines pharmacology, toxicology and pharmacoepidemiology to evaluate safety data, interpret emerging signals and contribute to benefit–risk assessment throughout the product lifecycle.
Whether you require scientific support for signal evaluation, literature assessment or pharmacovigilance training, we deliver tailored solutions designed to strengthen product safety and regulatory decision-making.
Scientific evaluation of potential safety signals using spontaneous reporting systems, published literature and evidence-based signal assessment methodologies.
Statistical evaluation of spontaneous reporting databases using internationally recognized disproportionality methods to support signal detection and safety evaluation.
Comprehensive scientific assessment integrating available safety and clinical evidence to support balanced benefit–risk evaluations throughout the product lifecycle.
Systematic review and critical interpretation of published safety evidence supporting pharmacovigilance activities and regulatory documentation.
Scientific interpretation of pharmacovigilance findings to support regulatory submissions, internal safety evaluations and scientific decision-making.
Scientific support for the evaluation of post-market safety information related to medical devices and vigilance activities where applicable.
Scientific guidance on the appropriate use of MedDRA terminology and coding principles to support accurate safety data interpretation and consistency.
Professional training programs covering pharmacovigilance principles, signal detection, MedDRA, benefit–risk assessment and current regulatory expectations for industry and academia.
Preparation of scientific reports supporting signal evaluation, literature review, benefit–risk assessment and post-market safety documentation.
Independent scientific expertise in pharmacovigilance and toxicology.
Experience in signal detection and disproportionality analysis.
Evidence-based interpretation of real-world safety data.
Regulatory-oriented scientific documentation.
Tailored solutions for industry, research organizations and academia.
Pharmacovigilance is the science and practice of detecting, assessing, understanding and preventing adverse effects or other medicine-related problems throughout the product lifecycle.
Signal detection is the process of identifying new or changing safety information that may indicate a potential association between a medicinal product and an adverse event requiring further scientific evaluation.
Disproportionality analysis is a statistical approach used to identify potential safety signals in spontaneous reporting databases by evaluating whether specific adverse events are reported more frequently than expected for a particular medicinal product.
Benefit–risk assessment integrates available evidence on efficacy and safety to determine whether the overall clinical benefits of a medicinal product continue to outweigh its potential risks throughout its lifecycle.
MedDRA (Medical Dictionary for Regulatory Activities) is the internationally standardized medical terminology used for coding, analyzing and communicating adverse event information in pharmacovigilance activities.
TOXENTRA provides independent scientific support through signal detection and evaluation, disproportionality analyses, literature review, benefit–risk assessment, MedDRA training and preparation of scientific safety reports tailored to project-specific needs.
Pharmacovigilance is more than regulatory compliance—it is a scientific discipline that supports safer medicines and informed decision-making. TOXENTRA provides evidence-based pharmacovigilance expertise tailored to the scientific and regulatory needs of each project.
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