Global Pharmacovigilance Services for Scalable Regulatory Compliance Across EU, UK, and Emerging Markets

Helping Marketing Authorization Holders (MAHs), Pharma Exporters, and Biotech Companies achieve 100% PV compliance, inspection readiness, and operational scalability with or without building internal PV infrastructure.

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EU GVP Compliance Ready

End-to-End PV Lifecycle Support

Scalable Global Delivery Model

ICH E2B(R3) Guidelines Aligned

Struggling with Pharmacovigilance Compliance?

Due to challenges with worldwide pharmacovigilance legislation, the pharmaceutical business struggled with scattered safety procedures, regulatory non-compliance from limited resources, like high costs and a lack of expertise, making it difficult to meet legal requirements and ensure global safety and compliance.

Medivigilax Research delivers end-to-end pharmacovigilance services, ensuring your products remain compliant throughout their lifecycle with affordable model. We act as an extension of your team, enabling you to focus on growth while we manage your drug safety obligations.

About Us

Medivigilax Research Pvt. Ltd. offers comprehensive global Pharmacovigilance and regulatory compliance solutions, including global literature monitoring, regulatory support, training, and Pharmacovigilance audits. Our innovative technology ensures safety and efficacy in pharmaceutical products throughout their lifecycle. We help pharmaceutical manufacturer and biotech firms ensure patient safety, regulatory compliance, and risk management throughout the product lifecycle. Our team of highly qualified professionals ensures compliance with global regulatory authorities.

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Global Pharmacovigilance & Drug Safety Services

Medivigilax offers comprehensive pharmacovigilance services to support the entire product lifecycle from clinical trials to post-marketing surveillance.

  • Pharmacovigilance System Setup & Maintenance

    We establish and maintain a robust pharmacovigilance system tailored to regulatory requirements.

  • Pharmacovigilance System Master File

    We develop and maintain the PSMF, a critical regulatory document for compliance for medicinal products. Furthermore, It provides an accurate reflection of the entire PV system.

  • Individual Case Safety Report (ICSR) Management

    Comprehensive management of adverse event reports from all sources.

  • Global Literature Monitoring

    Systematic screening of scientific literature for safety signals.

  • Signal Detection & Management

    Detection, validation, and evaluation of new or changing safety signals.

  • Aggregate Report Writing

    Comprehensive preparation and uphold of periodic safety reports like PSUR, PBRER, DSUR and RMP.

Why Medivigilax Research?

Medivigilax Research Private Limited is a leading pharmacovigilance service provider offering comprehensive drug safety and pharmacovigilance outsourcing solutions to pharmaceutical manufacturers who are Marketing Authorization Holders. Our expertise spans ICSR processing, aggregate reporting, Pharmacovigilance System Master File, signal detection, and risk management plans, ensuring full compliance with ICH guidelines, Good Pharmacovigilance Practices, and country specific regulatory guidelines. We deliver cost-effective, scalable, and inspection-ready pharmacovigilance services, helping organizations maintain global regulatory compliance and patient safety throughout the product lifecycle.

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Ensure Drug Safety & Compliance Today!

Partner with Medivigilax for world-class pharmacovigilance services

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