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PV Consultancy

We can support your company from the establishment of the pharmacovigilance system to the provision of advanced pharmacovigilance services

  • SOP development. From clinical stages to the postmarketing phase.

  • Adverse Event (AE) reporting policies.

  • Key Performance Indicators (KPI) and metric development to ensure compliance with GVP requirements.

  • Compliance monitoring and vendor oversight

  • Deviation and CAPA management

  • GVP Audits

  • Audit and inspection readiness

  • Pharmacovigilance training

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SOP Development

An essential element of any pharmacovigilance system is that there are clear written procedures in place. GVP Module I describes the required minimum set of written procedures for pharmacovigilance. 

We can support you in their development or improvement.

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