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Allied Safety Activities

Allied Safety Activities are a crucial component of a company’s comprehensive pharmacovigilance approach to ensure drug safety and efficacy. Artixio’s allied safety activities encompass a wide range of services beyond traditional adverse event monitoring including risk management planning, safety data exchange agreements, literature surveillance, and the development of Risk Evaluation and others to ensure our clients meet their product safety business objectives.

Audit & Inspection
Support

Audit readiness

Compliance monitoring

Periodic checks

Inspection support

CAPA management

Safety Data Exchange Agreement

Draft & Review the SDEA

Data collection & coordination

SDEA schedule & maintenance

SDEA renewal

SDEA archival

QPPV Office

EU-QPPV support

EA EU QPPV support

LPPV/LPVRP support

SPSMF management

Eudravigilance support

Affiliate Support

Local point of contact for country support

Local case intake & processing

Local HA communications & coordination

Handling of local PV activities

Technology Services

Safety database hosting & implementation

Validation support

Automation tool development

pharmacovigilance QPPV eudravigilance case intake processing

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Our experts will be delighted to assist you with your global business needs.

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