Pharmacovigilance & Drug Safety Services

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.

Comprehensive Drug Safety Solutions Across the Product Lifecycle

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

Pharmacovigilance System Setup & Maintenance Services

Build, optimize, and maintain a fully compliant pharmacovigilance system aligned with global regulatory requirements.

Fully Compliant Pharmacovigilance System

We help life sciences companies establish and maintain robust pharmacovigilance systems that ensure compliance with FDA, EMA, MHRA, and CDSCO regulations.

Pharmacovigilance System Master File (PSMF) Services

Ensure compliance with global regulations through a comprehensive and audit-ready PSMF.

Pharmacovigilance System Master File

We support the creation, maintenance, and updating of Pharmacovigilance System Master Files (PSMF/PvMF) as per global and country specific requirements.

ICSR Management & Case Processing Services

Accurate, compliant, and timely handling of adverse event case reports.

ICSR Processing & Submission

We provide end-to-end ICSR processing and submission services, ensuring compliance with global pharmacovigilance standards.

Global Literature Monitoring Services

Comprehensive monitoring of scientific literature to identify and manage safety signals.

Literature Monitoring

We conduct systematic global literature searches and reviews to ensure compliance with pharmacovigilance requirements.

Signal Detection & Risk Management Services

Proactively identify, evaluate, and mitigate drug safety risks.

Signal Management

Our signal detection services leverage advanced analytics and expert evaluation to ensure proactive safety management.

Aggregate Report Writing Services

Compliant and high-quality periodic safety reports for global regulatory submissions.

Safety Reports Writing

We provide expert aggregate safety report writing services (PSUR, PBRER, DSUR), ensuring compliance with international regulatory standards.

⚙️ DELIVERY MODEL

Flexible & Scalable Engagement Models

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.

Flexible Engagement Models

Full-service outsourcing, dedicated FTE, or project-based support

Global Compliance Framework

Aligned with ICH, EU GVP, US FDA, MHRA,WHO and country specific guidelines

Technology-Enabled Operations

Advanced safety databases, automation, and real-time reporting

Scalable Infrastructure

Supports growth across EU, UK, US, Africa, APAC and emerging markets

Quality & Audit Readiness

Built on robust QMS and inspection-ready processes

🌍GLOBAL COMPLIANCE

Aligned with Global Regulatory Standards

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.

Let's handle your drug safety and compliance needs, so you can focus on innovation and growth

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