Comprehensive, compliant, and scalable pharmacovigilance solutions tailored for pharmaceutical, biotech, and CRO organizations.
From case processing to risk management and regulatory submissions, we ensure your products remain safe, compliant, and market-ready.
At Medivigilax, we deliver end-to-end pharmacovigilance services that support the entire lifecycle of medicinal products from clinical development to post-marketing surveillance.
Our solutions are designed to:
✔ Ensure global regulatory compliance
✔ Enhance operational efficiency
✔ Reduce risk and turnaround time
Build, optimize, and maintain a fully compliant pharmacovigilance system aligned with global regulatory requirements.
We help life sciences companies establish and maintain robust pharmacovigilance systems that ensure compliance with FDA, EMA, MHRA, and CDSCO regulations.
Ensure compliance with global regulations through a comprehensive and audit-ready PSMF.
We support the creation, maintenance, and updating of Pharmacovigilance System Master Files (PSMF/PvMF) as per global and country specific requirements.
Accurate, compliant, and timely handling of adverse event case reports.
We provide end-to-end ICSR processing and submission services, ensuring compliance with global pharmacovigilance standards.
Comprehensive monitoring of scientific literature to identify and manage safety signals.
We conduct systematic global literature searches and reviews to ensure compliance with pharmacovigilance requirements.
Proactively identify, evaluate, and mitigate drug safety risks.
Our signal detection services leverage advanced analytics and expert evaluation to ensure proactive safety management.
Compliant and high-quality periodic safety reports for global regulatory submissions.
We provide expert aggregate safety report writing services (PSUR, PBRER, DSUR), ensuring compliance with international regulatory standards.
Medivigilax Research delivers flexible, scalable, and compliance-driven pharmacovigilance solutions tailored to meet the evolving needs of global pharmaceutical and biotech companies. Our delivery model is designed to ensure end-to-end drug safety management, seamless regulatory compliance, and operational efficiency across multiple markets.
We offer a hybrid engagement approach, combining centralized expertise with global execution, enabling clients to scale pharmacovigilance operations without infrastructure burden. Whether supporting Marketing Authorization Holders (MAHs) or emerging pharma exporters, our model ensures timely case processing, accurate reporting, and full regulatory alignment.
Full-service outsourcing, dedicated FTE, or project-based support
Aligned with ICH, EU GVP, US FDA, MHRA,WHO and country specific guidelines
Advanced safety databases, automation, and real-time reporting
Supports growth across EU, UK, US, Africa, APAC and emerging markets
Built on robust QMS and inspection-ready processes
Medivigilax Research ensures seamless global pharmacovigilance compliance across regulated, semi-regulated and emerging markets, enabling pharmaceutical and biotech companies to meet evolving international regulatory requirements with confidence. Our solutions are aligned with ICH guidelines, EU GVP modules, US FDA regulations, and MHRA standards and country specific regulatory standards ensuring consistent drug safety monitoring and reporting worldwide.
We support Marketing Authorization Holders (MAHs) and pharma exporters with end-to-end pharmacovigilance services, including ICSR processing, safety database management, aggregate reporting, signal detection, and Risk Management Plans (RMPs) ensuring full compliance, inspection readiness, and patient safety across all regions.
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