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Global Pharmacovigilance & Drug Safety Services
Eignapharma offers comprehensive pharmacovigilance services designed to monitor and ensure the safety of pharmaceutical products throughout their entire lifecycle. Our expert team is dedicated to helping pharmaceutical companies comply with complex global regulations while protecting patient health.
Pharmacovigilance is the science and activities related to detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. Our services cover all aspects from adverse event monitoring and data collection to risk management and regulatory reporting.
OUR SERVICES
Adverse Event Monitoring
Continuous collection, analysis, and evaluation of spontaneous and clinical trial reports to detect potential safety signals.
Risk Assessment and Management
Identification and quantification of risks associated with pharmaceutical products, development of Risk Management Plans (RMPs), and execution of risk minimization measures.
Regulatory Reporting
Preparation and submission of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and other mandatory safety documents to health authorities on time and in compliance with regulations.
Safety Database Management
Use of validated pharmacovigilance databases compliant with standards such as PV E2B R3 for efficient case data handling.
Compliance Audits and Inspections Support
Assistance during regulatory inspections, audits, and pharmacovigilance system master file (PSMF) maintenance.
Training and Consulting
Building in-house pharmacovigilance capabilities through tailored training and expert consultancy.
Partnering with Eignapharma gives your organization the confidence to meet evolving pharmacovigilance requirements worldwide while prioritizing patient safety and regulatory excellence.