Product Safety Management

  • Regulatory services, documents and data management
  • Assistance for dossier preparation, production, submission and maintenance
  • Product Safety Management

Pro active safety and pharmacovigilance

  • Definition and implementation of risk management governance
  • Preparation and implementation of risk management plans and Risk Evaluation and Mitigation Strategies
  • Preparation of safety specific documentation
  • Assistance in risk/benefit balance evaluation
  • Consultancy and medical advice
  • Introduction of signal detection processes and tools, bibliographic searches and PV management systems (SOPs and DDPs)
  • PV database management, bibliographic searches, safety documentation and reports (ICSRs / SUSARs, PSURs / CESs / ASRs)
  • Provision of EU Qualified Person(s) for Pharmacovigilance (QPPV)
  • Preparation to audit and inspection.

More information

Latest News

Monday 26.03.2012
Exhibition in Copenhagen: Join us at the 24th DIA Euromeeting
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Monday 30.01.2012
Conférence à Paris: ProductLife participe à l'évènement sur la Cosmétovigilance organisé par la FEBEA
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Tuesday 24.01.2012
Kompaktseminar in Berlin: EVMPD - praktische Umsetzung bis Juli 2012
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