Pharmacovigilance
We guarantee security...
In a constantly evolving regulatory environment, ensuring drug safety is critical for patient protection and regulatory compliance. We provide comprehensive solutions for adverse event monitoring and management:
Monitoring and Management of Adverse Events
Collection, analysis and reporting of adverse events.
Causality assessment and safety signal management.
Compliance with international regulations (ICH, EMA and FDA).
Preparation of Periodic Safety Reports (PSUR)
Review and analysis of global safety data.
Drafting reports in accordance with regulatory standards.
Submission of reports to the competent authorities.
Risk Management Plans (RMP)
Development and updating of risk minimization strategies.
Measures to improve drug safety.
Safety Data Collection, Analysis, and Reporting
Databases for security information management.
Generation of metrics and trend analysis.
Compliance with post-marketing pharmacovigilance requirements.
Our services ensure the safety of your products, comply with regulations, and maintain the trust of patients and healthcare professionals. Contact us to develop a customized strategy for your company.