EudraVigilance Compliance
EudraVigilance Compliance
Pharmacovigilance Data Management & EudraVigilance Compliance
Secure Your Safety Data Flows and European Regulatory Obligations
The quality, traceability, and compliance of pharmacovigilance data are critical challenges for Marketing Authorization Holders (MAHs), pharmaceutical companies, and Life Sciences organizations operating in Europe.
Within a regulatory framework governed by Good Pharmacovigilance Practices (GVP) and EMA requirements, effective control of EudraVigilance data flows and safety data management is essential to:
– ensure regulatory compliance
– maintain reliability of safety data
– comply with regulatory reporting timelines
– support Signal Management activities
– reduce risks during pharmacovigilance inspections
Atessia Vigilances supports pharmaceutical companies, biotech firms, and MAHs in the management, oversight, and security of pharmacovigilance data across France and Europe.
Our objective : to ensure the integrity of your safety data and maintain robust compliance of your EudraVigilance activities.
Pharmacovigilance Data Management
Ensure the Quality and Consistency of Your Safety Data
Pharmacovigilance data form the foundation of healthcare product benefit-risk monitoring systems.
Atessia Vigilances supports:
– Management of ICSR-related data
– Safety data quality control
– Verification of medical and regulatory data consistency
– Follow-up management and missing data tracking
– oversight of case processing workflows
– coordination of local and global activities
A rigorous approach designed to ensure reliability, consistency, and traceability of safety data.
EudraVigilance Compliance
Meet European Regulatory Requirements
EudraVigilance is a central pillar of the European pharmacovigilance system and imposes strict requirements regarding data quality and regulatory reporting.
Our teams support you with:
- management of regulatory submissions to EudraVigilance
- monitoring of reporting obligations
- oversight of regulatory timelines
- supervision of E2B data flows
- management of acknowledgements and system errors
- reconciliation of safety data
Controlled compliance processes designed to secure your European regulatory obligations.
Quality Control & Data Integrity
Secure the Integrity of Your Safety Data
Health authorities place particular focus on safety data quality and integrity during pharmacovigilance inspections.
Atessia Vigilances implements quality control systems enabling:
- case quality reviews
- consistency checks of regulatory data
- MedDRA coding reviews
- analysis of discrepancies and anomalies
- implementation of quality indicators (KPIs)
- follow-up of continuous improvement plans
Robust processes designed to ensure reliable, auditable, and compliant safety data aligned with EMA and ANSM expectations.
Regulatory Data Flows & E2B Oversight
Strengthen Control Over Your Regulatory Exchanges
Management of E2B data flows requires continuous oversight to ensure compliant exchanges with authorities and business partners.
Our experts support:
- supervision of E2B exchanges
- monitoring of regulatory transmissions
- analysis of transmission errors and rejections
- support for system migrations and upgrades
- coordination with IT and safety teams
- security of regulatory interfaces
Operational control of data flows designed to reduce the risk of non-compliance.
Inspection Readiness
Prepare Effectively for EMA and ANSM Inspections
Activities related to pharmacovigilance data and EudraVigilance are key focus areas during regulatory inspections.
Atessia Vigilances supports organizations with:
- safety data compliance reviews
- data quality audits
- regulatory gap assessments
- review of EudraVigilance processes
- preparation of documentation
- pharmacovigilance mock inspections
An inspection-ready approach designed to strengthen compliance levels and reduce regulatory risk exposure.
An Integrated Quality Approach
Processes Designed to Ensure Compliance and Traceability
Our activities are integrated into a quality system compliant with Good Pharmacovigilance Practices (GVP) and European regulatory requirements.
We ensure:
- documented and auditable workflows
- full traceability of activities
- appropriate quality controls
- oversight of critical processes
- data governance aligned with EMA expectations
A robust organization designed to sustainably secure your pharmacovigilance activities.
Why Choose Atessia Vigilances?
Recognized Expertise in Regulatory Pharmacovigilance
Experienced consultants specialized in safety data management, EudraVigilance, and PV compliance.
Strong Knowledge of French and European Regulatory Requirements
Compliance with EMA, ANSM, GVP, and EudraVigilance expectations.
An Inspection-Ready Mindset
Processes designed to support audits and inspections by health authorities.
Integrated Safety & Compliance Expertise
Data management, regulatory reporting, and PV governance coordinated within the same organization.
Flexible and Tailored Solutions
Outsourcing, operational support, or strategic consulting according to your organizational needs.
What You Gain by Working with Us
– Secured European regulatory data flows
– Improved safety data quality
– Reduced risk of non-compliance
– Strengthened EudraVigilance compliance
– Enhanced preparedness for EMA and ANSM inspections
Looking for an Expert Partner in Safety Data Management & EudraVigilance?
Atessia Vigilances supports pharmaceutical companies, biotech firms, and Life Sciences organizations in securing, supervising, and maintaining compliant pharmacovigilance data activities across France and Europe.