Ensuring Patient Safety Throughout the Product Lifecycle
Shudarsana provides comprehensive Pharmacovigilance services that help pharmaceutical, biotechnology, and healthcare organizations monitor, assess, and manage the safety of medicinal products. Our experienced team supports global regulatory compliance while helping organizations maintain robust drug safety systems and protect patient well-being.
Protecting Patients Through Continuous Safety Monitoring
Pharmacovigilance plays a critical role in ensuring that medicines remain safe throughout their lifecycle. Effective safety monitoring extends beyond regulatory compliance—it involves continuous surveillance, accurate case processing, medical evaluation, literature monitoring, risk assessment, and timely reporting to global health authorities. At Shudarsana, we combine scientific expertise with structured workflows to support pharmaceutical companies in maintaining high-quality pharmacovigilance operations. Our services are designed to strengthen safety systems, improve compliance, streamline reporting activities, and contribute to better patient outcomes across global markets.
Our Pharmacovigilance Services
Comprehensive drug safety solutions designed to support regulatory compliance, patient protection, and efficient pharmacovigilance operations throughout the product lifecycle.
Case Processing
Accurate processing of Individual Case Safety Reports (ICSRs), including data entry, narrative writing, quality review, medical coding, and complete lifecycle management.
Literature Monitoring
Comprehensive local and global literature surveillance to identify, evaluate, and report adverse events in accordance with regulatory pharmacovigilance requirements.
Signal Detection
Continuous monitoring and analysis of safety data to identify emerging safety signals, trends, and potential risks requiring medical evaluation.
Medical Review
Medical assessment of adverse events including causality evaluation, case validation, clinical consistency review, and scientific documentation support.
Aggregate Reports
Preparation and support for PSURs, PBRERs, DSURs, annual reports, and other aggregate safety submissions required by health authorities.
Risk Management
Support for Risk Management Plans (RMPs), benefit-risk evaluations, safety documentation, and implementation of risk minimization activities.
Regulatory Compliance
Pharmacovigilance support aligned with ICH guidelines, GVP modules, FDA, EMA, MHRA, CDSCO, and other international regulatory expectations.
Safety System Support
Assistance with pharmacovigilance quality systems, SOP development, CAPA management, inspections, audits, compliance documentation, and operational improvements.