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Safety Surveillance

Comprehensive Safety Surveillance services to ensure the ongoing safety and efficacy of pharmaceutical products. Artixio’s services involve the continuous monitoring and evaluation of adverse events and other safety data collected from various sources. The process includes signal detection, risk assessment, and trend analysis to identify potential safety concerns. Additionally, Artixio provides detailed safety reports and ensure compliance with global regulatory requirements.

safety surveillance pharma medical device

Medical Writing

PADER/PSUR/PBRER/DSUR

Authoring

Review

Publishing

Submission

Aggregate report scheduling
Adhoc reports
safety surveillance pharma medical device

Signal Management

Signal Detection

Quantitative Analysis

Qualitative Analysis

Signal Validation

Potential Signal

Valid Signal

Refuted Signal

Signal Prioritization

Risk Management

Health Hazard Assessment
New RMP authoring
RMP Updates
RMP maintenance
Risk Evaluation & mitigation strategy
safety surveillance pharma medical device
safety surveillance pharma medical device

Get in touch

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

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