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Consultant Activities
PVigi – Your Trusted Pharmacovigilance Consulting
CRO Activities
Contract Research Organisation In addition to
Our Services
At PVigi, we specialize in delivering top-tier pharmacovigilance services across Turkey, Europe, the Middle East, and Africa. Our expertise ensures compliance with global regulations while maintaining the highest standards of safety monitoring and risk management.
Drug Safety
We provide comprehensive pharmacovigilance solutions, including case processing, signal detection, and regulatory reporting, ensuring drug safety with international guidelines.
Clinical Trial Services
PVigi supports clinical research and regulatory submissions with high-quality data management, literature review, and safety monitoring to help bring innovative treatments to market.
Freelance and Part-timers
Our expert consultants offer strategic guidance on regulatory requirements, quality management, and risk minimization measures to help pharmaceutical companies meet industry standards.
Why We Are Different?
Our Expertise & Experience
With years of experience in pharmacovigilance and regulatory services, we ensure compliance and patient safety across Turkey, Europe, the Middle East, and Africa.
Commitment to Excellence
Our mission is to deliver high-quality, customized solutions that help our clients meet global pharmacovigilance standards.
Flexible & Tailored Solutions
We adapt to your specific needs, offering scalable and customized pharmacovigilance services that align with your regulatory and business requirements.
Our Capabilities
We offer expert pharmacovigilance solutions to ensure regulatory compliance and patient safety across Turkey, Europe, the Middle East, and Africa
Thorough monitoring of local medical journals to detect and assess safety signals, ensuring timely regulatory compliance
Development and implementation of tailored RMPs to minimize product-related risks and enhance patient safety.
Qualified Local and EU QPPV services to meet regional requirements and ensure pharmacovigilance oversight.
Continuous monitoring of evolving pharmacovigilance regulations to keep your operations compliant and up to date.
Timely and accurate submission of ICSRs, PSURs, SUSAR, DSUR and other regulatory reports to health authorities, ensuring compliance.
Regulatory support for product launches approval, pricing, ensuring compliance with local and international requirements
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Frequently Asked Questions
Find answers to common questions about our pharmacovigilance consulting services.
Pharmacovigilance (PV) is the science of detecting, assessing, understanding, and preventing adverse effects of medicines. It ensures patient safety and regulatory compliance.
We offer expert consulting on case processing, regulatory intelligence, signal management, and risk mitigation. Our services ensure that your company meets the strictest compliance standards in Turkey, Europe, the Middle East, and Africa.
Yes! We tailor our services to your company's needs, whether you're a pharmaceutical company, biotech firm, or clinical research organization (CRO). Our solutions are designed to align with your operational structure and regulatory requirements.
Our services align with regulations from agencies such as the European Medicines Agency (EMA), the Turkish Medicines and Medical Devices Agency (TİTCK), the U.S. Food and Drug Administration (FDA), and other global health authorities.
Absolutely! We provide customized pharmacovigilance training programs, covering regulatory updates, case processing, and best practices to ensure your team stays ahead in compliance and safety monitoring.
