Pharmacovigilance

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What we provide in this stream

Our specialized team delivers high-quality, customized pharmacovigilance solutions. We prioritize patient safety, regulatory compliance, and optimizing the risk-benefit profile of your products to drive success. Whether it is individual PV tasks or managing global systems, our services are tailored to your specific needs. Supporting clinical trials and marketing authorization holders, we ensure efficiency and excellence at every stage.

PV Solutions

Continuous Safety Monitoring

Ongoing surveillance of product safety throughout its lifecycle, combining real-time data analysis with regulatory updates. This ensures sustained compliance and proactive risk management for optimal patient outcomes.

Post-Authorization Safety Study (PASS)

Tailored PASS solutions to assess the safety and efficacy of your products in real-world settings. We design, execute, and analyse studies that fulfil regulatory obligations and enhance product safety profiles.

PSMF (Pharmacovigilance System Master File)

Comprehensive creation and maintenance of the PSMF, a critical document outlining your pharmacovigilance system. Our expertise ensures alignment with global regulations and inspection readiness.

QPPV (Qualified Person for Pharmacovigilance)

Our QPPV services provide expert oversight for pharmacovigilance systems, ensuring compliance with EU regulatory requirements. This includes managing safety data, reporting obligations, and regulatory interactions.

Signal Management

Advanced methodologies for detecting and evaluating safety signals ensure early identification of risks. Our signal management process includes prioritization, investigation, and communication to support regulatory compliance and patient safety.

Risk Management

Tailored risk management plans (RMPs) and mitigation strategies help identify, assess, and minimize potential safety concerns. We ensure that your products meet regulatory expectations while safeguarding public health.

Hallmarks of Our Pharmacovigilance Solutions

Our PV solutions are meticulously designed to meet global regulatory standards, ensuring seamless compliance across regions.

From specific activities to complete PV system setup, we customize our services to align with client needs and product portfolios.

We focus on assessing and enhancing the risk-benefit profiles of products, safeguarding patient safety while maximizing market potential.

Our solutions are adaptable, supporting local requirements and expanding effortlessly to meet global pharmacovigilance demands.

By leveraging advanced tools and analytics, we streamline processes like case management, signal detection, and reporting for optimal efficiency.

Hallmarks of Our Pharmacovigilance Solutions

Our PV solutions are meticulously designed to meet global regulatory standards, ensuring seamless compliance across regions.

From specific activities to complete PV system setup, we customize our services to align with client needs and product portfolios.

We focus on assessing and enhancing the risk-benefit profiles of products, safeguarding patient safety while maximizing market potential.

Our solutions are adaptable, supporting local requirements and expanding effortlessly to meet global pharmacovigilance demands.

By leveraging advanced tools and analytics, we streamline processes like case management, signal detection, and reporting for optimal efficiency.

From ICSR case processing to aggregate reporting and post-authorization studies, we provide comprehensive support throughout the product lifecycle.

Our team of seasoned PV professionals, including QPPVs and medics, ensures robust safety monitoring and insightful decision-making.

Continuous surveillance identifies potential safety issues early, allowing timely action to mitigate risks.

We prioritize clarity and transparency in all interactions, keeping clients informed and confident in every aspect of pharmacovigilance management.

Talk to Our Experts

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Why Choose Us

Experience

Our team includes seasoned PV professionals, medics, and QPPVs with extensive experience in global pharmacovigilance regulations and practices.

Quality

Quality

We ensure adherence to global pharmacovigilance standards, including ICH, EMA, FDA, and WHO, backed by robust quality assurance processes designed to deliver accurate, consistent, and fully compliant solutions tailored to your needs.

Cost-Efficiency

We provide cost-efficient pharmacovigilance solutions by optimizing workflows and leveraging advanced technologies, ensuring high-quality compliance without exceeding your budget.

Strong Client Support

Our approach to client support is rooted in partnership, offering proactive guidance, tailored strategies, and unwavering responsiveness to ensure your success at every stage of pharmacovigilance.

Customized value at every step

Our solutions are designed to align with your specific operational and compliance objectives, combining flexibility, precision, and cost-effectiveness to meet your business goals.