With our dedicated team of pharmacovigilance specialists, we maintain a robust pharmacovigilance system. It adheres to the highest standards of our partners, as well as EU and local regulations, prioritizing patient safety.Teja PoglajenGlobal Drug Safety Manager, EEA QPPV

Pharmacovigilance

Our comprehensive and fully compliant pharmacovigilance system adheres to the highest industry standards, Good Pharmacovigilance Practices (GVP), EU and local regulations. Designed to guarantee patient safety, it incorporates a robust quality management system and supports the expectations and standards of our partners.

We keep the pharmacovigilance system audit- and inspection-ready at all times, incorporating the latest requirements for digitalization, data security, and business continuity.

Our pharmacovigilance services include:

  • Local Qualified Persons for Pharmacovigilance with 24/7 availability
  • Management of safety information reports
  • Local literature and regulatory intelligence
  • Submissions and communication with local regulatory authorities
  • Local adaptation and distribution of risk minimization measures

Benefits of Cooperating with Us

  • Comprehensive pharmacovigilance system
  • Single point of contact for all markets
  • Strict safety reporting system
  • Strong quality and compliance mindset 
  • Effective project management 

Reach out to explore the potential of partnering with us, while ensuring that patient safety in Central and Eastern Europe is a top priority.

Contact us

With our dedicated team of pharmacovigilance specialists, we maintain a robust pharmacovigilance system. It adheres to the highest standards of our partners, as well as EU and local regulations, prioritizing patient safety.Teja PoglajenGlobal Drug Safety Manager, EEA QPPV

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