The Need for Pharmacovigilance Document Translation
Pharmacovigilance (PV) plays a crucial role in monitoring drug safety worldwide. Regulatory agencies require precise documentation in multiple languages for compliance, adverse event reporting, and safety assessments. Misinterpretations due to poor translations can lead to regulatory challenges, market withdrawal, or patient safety risks.
Why Choose Alchemy for PV Document Translation?
- End-to-End Safety Documentation – Expertise in preparing high-quality ICSRs, RMPs, and PSMFs.
- Compliant Risk Management – Comprehensive drafting of Risk Management Plans as per regulatory expectations.
- Signal Detection & Assessment – Accurate reporting supported by robust analysis and global compliance.
- Regulatory Readiness – Aligned with EMA, MHRA, and global authorities for seamless submissions.
1500
ICSRs Translated
0.5%
Inspection-Ready
100%
GDPR secured
20
Markets Served
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