Your Trusted Partner for European Pharmacovigilance Services
Pharmaceutical companies, biotech innovators, and medical - device manufacturers entering the EU must meet one of the most structured drug - safety requirements in the world.The European Medicines Agency(EMA) enforces a harmonized and highly monitored pharmacovigilance framework, supported by Good Pharmacovigilance Practices(GVP) and mandatory post - market safety reporting.
DDReg supports organizations across the lifecycle of their medicinal product with European Pharmacovigilance Services, EU QPPV services, and local safety operations across member states. Our role is to ensure compliance with EudraVigilance, EMA, and national competent authority (NCA) expectations while maintaining operational efficiency and patient safety.
Understanding Pharmacovigilance in the European Union
The EMA defines pharmacovigilance as the scientific and regulatory process for monitoring, detecting, assessing, understanding, and preventing adverse drug reactions and other medicine - related problems in the European region.
Every Marketing Authorization Holder (MAH) in the EU must operate a validated PV system. This includes:
- An appointed EU Qualified Person for Pharmacovigilance (EU QPPV)
- A maintained Pharmacovigilance System Master File (PSMF) located in the EU/EEA
- Mandatory submission of safety reports through EudraVigilance
- Continuous signal detection and benefit–risk evaluation
- Market-specific safety communication and risk-minimization activities
Failure to comply may lead to regulatory warnings, fines, legal implications, suspension, or withdrawal of product authorization.
Key Regulatory Components in the EU Pharmacovigilance Framework
| Requirement | Purpose | Applicability |
|---|---|---|
| EU QPPV | Oversight of the pharmacovigilance system, 24/7 compliance responsibility | Mandatory for all MAHs |
| PSMF | Documentation of the organization's EU PV system | Mandatory and inspection-ready |
| ICSR Reporting via EudraVigilance | Case management and reporting of adverse events | Mandatory post-authorization |
| Periodic Safety Update Reports (PSURs) | Benefit-risk assessment based on global data | As scheduled by EMA/NCA |
| Risk Management Plans (RMPs) | Stratified monitoring for high-risk or newly authorized products | Required at and post approval |
Our Pharmacovigilance Services in the European Union
DDReg provides full - scope and modular EU pharmacovigilance services to support compliance for authorized, pipeline, and legacy products.
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EU QPPV and Local QPPV Services
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EudraVigilance and ICSR Management
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Aggregate Safety Reporting
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Signal Management and Risk Minimization
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PV Outsourcing and Strategic Consulting
Our role extends beyond execution. DDReg strengthens your regulatory posture, safeguards your license, and ensures a resilient pharmacovigilance infrastructure.
Industries We Support
| Segment | Scope of Support |
|---|---|
| Pharmaceutical Companies | Full post-authorization safety compliance |
| Biotechnology Innovators | EU entry strategy, QPPV, PSMF, safety setup |
| Medical Device Manufacturers | Combination product PV support |
| Generics and Biosimilars | Lifecycle management and regulated submissions |
| Virtual and Small MAHs | Fully outsourced EU pharmacovigilance function |
Why DDReg for European Drug Safety Services
- Proven operational capability across EMA and EU member-state expectations
- Pragmatic approach to achieving both compliance and operational scalability
- A single integrated PV framework for multiple products and markets
- Technology-enabled workflows supporting predictable safety governance
Our Pharmacovigilance (PV) Services Expertise
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