EudraVigilance Services
Simplify compliance with EudraVigilance requirements
Managing and analyzing safety data for medicinal products is crucial for regulatory compliance in the European Union. At QbD Group, we provide specialized EudraVigilance services to ensure your submissions meet all EMA requirements. From electronic reporting to MedDRA licensing and market authorization support, we streamline the process to help you focus on what matters most: developing safe and effective medicines.
What is the EudraVigilance Medicinal Product Dictionary (XEVMPD)?
The XEVMPD is a centralized database maintained by the European Medicines Agency (EMA) to record information on medicinal products authorized in the European Union. It supports electronic reporting of suspected adverse reactions and ensures regulatory compliance across the lifecycle of your product. Key aspects of XEVMPD:
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Data entry and validation: Accurate and complete recording of product information.
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Prerequisite management: Assistance with obtaining MedDRA licenses, EUCT (CTIS) numbers, and ensuring readiness for electronic submissions.
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Electronic reporting: Ensuring your adverse reaction data is correctly submitted via EudraVigilance.
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Market authorization support: Guidance for obtaining and maintaining EU market approvals.
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Regulatory updates: Continuous monitoring of EMA requirements to keep your data compliant.
Why is XEVMPD compliance essential?
Meeting EudraVigilance requirements is not only mandatory for EU market access but also ensures the safety and efficacy of your medicinal products. Here’s why compliance matters:
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Regulatory adherence: Avoid penalties and maintain market access by meeting EMA reporting standards.
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Data transparency: Contribute to a robust pharmacovigilance system that protects public health.
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Operational efficiency: Streamline data management to reduce administrative burdens.
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Market confidence: Build trust with regulators, stakeholders, and patients through accurate safety data.
How can we help?
Prerequisite preparation
Comprehensive data management
Comprehensive data management
Accurate entry and validation of medicinal product data in the XEVMPD.
Regulatory submissions
Regulatory submissions
Expert support for timely and compliant reporting of adverse reactions.
Market authorization support
Market authorization support
Assistance with obtaining and maintaining EU approvals for your products.
Customized solutions
Customized solutions
Tailored workflows to meet the unique requirements of your product portfolio.
Why partner with QbD Group?
When you choose QbD Group for EudraVigilance support, you benefit from:
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Regulatory expertise: Decades of experience in pharmacovigilance and regulatory compliance.
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Tailored solutions: Custom workflows designed to meet your operational needs.
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Proven processes: A track record of successful submissions and satisfied clients.
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End-to-end support: From initial data entry to continuous compliance monitoring, we’re with you every step of the way.