Ensuring Drug Safety Through Expertise
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems. At Feyti Medical Group, we play a central role in ensuring patient safety by providing full-spectrum pharmacovigilance services to pharmaceutical and biopharmaceutical companies.
From the moment a drug enters clinical trials to its post-market distribution, our experts continuously monitor its safety profile. We ensure that all reported adverse events are systematically collected, medically evaluated, and reported to the appropriate health authorities according to global regulatory standards. This process allows healthcare professionals and regulatory bodies to respond quickly to emerging safety concerns, minimizing risk to patients.
Our work involves active signal detection, detailed benefit-risk assessments, preparation of regulatory documents such as PSURs and DSURs, and support during audits and inspections. We understand the complexity of global regulations (such as those from the FDA, EMA, and WHO), and we help our clients maintain compliance through a combination of automation tools, expert reviews, and real-time safety surveillance.
Whether you are launching a new drug, expanding into new markets, or simply need to upgrade your existing safety systems, Feyti offers scalable solutions tailored to your needs. Our goal is not only to comply with regulatory requirements but also to ensure that medicines are used as safely as possible by the patients who need them.
Our Pharmacovigilance Capabilities
📝 Case Processing
We manage the complete cycle of Individual Case Safety Reports (ICSRs), from initial intake to submission. This includes clinical trial data, spontaneous reporting, digital platforms, and literature. Each report is reviewed by qualified pharmacovigilance professionals to ensure medical relevance and compliance.
📊 Aggregate Reporting
Our team prepares Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs) tailored to local and international standards. These reports offer comprehensive safety evaluations and are vital for regulatory reviews.
👨⚕️ QPPV Support
We provide Qualified Persons for Pharmacovigilance (QPPVs) who ensure that your safety systems operate effectively and remain inspection-ready at all times. These professionals are registered and trained under EU and global frameworks.
🔍 Audit & Inspection Readiness
We help clients prepare for audits and inspections by offering mock audits, SOP reviews, and training. Our experts simulate real inspection conditions to help your teams respond confidently to regulators.
📚 Literature Monitoring
Continuous surveillance of scientific and medical literature allows us to identify new safety signals. We ensure timely extraction, assessment, and reporting of relevant adverse event information, contributing to a robust pharmacovigilance system.