P V I G I

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Why Choose Us

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OUR MISSION

We Offer the Best Solution

Regulatory Compliance Across Multiple Regions

Active Regulatory Intelligence

Navigating pharmacovigilance regulations in Turkey, the EU, the Middle East, and Africa requires extensive expertise. PVigi ensures full compliance with EMA, MHRA, GCC, SFDA, and Turkish TİTCK regulations, adapting to region-specific requirements.

Comprehensive PV Solutions

Full Service Capability

From literature screening, case management, signal detection, risk management, and periodic safety reports to local QPPV services, our consultancy covers the full spectrum of PV needs.

Global Expertise, Local Understanding

Freelance or Consultant Capability

With a deep understanding of country-specific regulations, we provide tailored solutions that align with both global and national pharmacovigilance requirements.

Cost-Effective Outsourcing

We offer cost-effective solutions

Reduce operational burden while ensuring compliance and efficiency. Our outsourced PV solutions allow you to focus on product development while we handle safety monitoring and reporting.

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.