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Partner with Viginovix to ensure patient safety regulatory compliance and data-driven insights.

Who We Are

we specialize in providing comprehensive solutions in Pharmacovigilance and Regulatory Affairs to pharmaceutical companies worldwide

Our Comprehensive Pharmacovigilance Service Offerings

pharmacovigilance

Case Management

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  • ICSR Management

  • Literature Review & Screening

  • SAE & SUSAR Management

  • Migration of PV Data

  • Medical Review of ICSRs

  • Submissions

Insurance Consultation

 Risk & Signal Management

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  • Signal Detection & Management

  • Benefit Risk Management

  • US-REMS

  • Additional Risk Monitoring Plans

  • Health Inquiries/Request to Question Responses

europe/uk services

 Europe/UK Based Services

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  • PV Audit as-a-service

  • QPPV Services

  • Eudravigilance Setup and Maintenance   

  • PSMF Setup and Maintenance

scientific writing

 Scientific Writing Services

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  • Aggregate Reports

  • Clinical Development Plan

  • Clinical Study Report (CSR)

  • Clinical Study Protocol

  • Common Technical Document (CTD)

consulting

 Consulting & Strategy

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  • PV Management Consulting

  • Regulatory Intelligence

  • PV process automation

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