Pharmacovigilance Support
Ensure patient safety and regulatory compliance with our robust Pharmacovigilance Services. We provide end-to-end solutions for drug safety monitoring, enabling you to fulfil post-market surveillance requirements seamlessly. Our services include:
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Individual Case Safety Report (ICSR) management: Processing, Quality review, Medical review and Global reporting.
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Safety Data Management and Global Safety Database
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Aggregate report writing - PSUR, DSUR, PBRER, PADER, ACOs and Risk Management
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Preparation of Pharmacovigilance System Master File (PSMF/PvMF)
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Risk Management Plan (RMP)
Clinical Services
Accelerate clinical development with our tailored Clinical Services designed to deliver accurate and reliable results while ensuring regulatory adherence. Our offerings include:
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PSUR/RMP
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Clinical Trials
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Safety, Efficacy & Literature Reporting
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BA/BE Studies
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BTIF / Biowaiver Form
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SmPC/PIL/Insert Writing