Pharmacovigilance

We are offering tailored solutions for pharmacovigilance and related services in product safety monitoring according to international GVP standards.

We are committed to always help companies monitor the safety of their drugs. Our holistic strategy englobe:

  • Case Management

    • Case triage, Data entry, QC
    • Coding MedDRA – WHO Drug
    • Medical Revision, Causality, Expectedness Assessment
    • Notification of SAEs to Authorities, Ethics committees

 

  • Safety aggregate Report Writing

    • PSURs, DSURs, PBRERs, PAERs, RMPs, SMRs
    • Database outputs and line listing generation
    • Quality control based on Peer-Review and Medical Review

 

  • Literature Screening and Review

    • Frequent review of scientific literature including medical assessment
    • Search Strategy definition
    • Embase and Medline databases

 

  • 24/7 coverage hotline

    • Availability of any medical and safety issues or questions related to products
    • Phone/ Email/ Fax