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Pharmacovigilance Consultants

It is incumbent upon pharmaceutical companies today to conduct a comprehensive drug safety and pharmacovigilance audit.

This audit identifies the hazards associated with pharmaceutical products and minimises the risks of patient harm while ensuring compliance.

Starting with this audit, Explic8’s expert team transforms your safety processes to stay compliant with international laws and regulations. We have a proven track record of improving compliance, data quality and efficiency while reducing cost and complexity in the pharmaceutical industry.

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End-to-end support across your organisation

  • Organisational Design

    Our consultants have the expertise to help you define the pathway forward, ensuring your organisation is adequately resourced for ongoing PV requirements, from your people to your processes, reporting and technologies.

  • PV Process Design

    We guide your end-to-end PV process design, ensuring it is sustainable, efficient, compliant and fully cross-functional. Our in-depth and proven approach ensures you tick all the boxes across ICSR, literature, labelling, PSPs, signal detection and reporting.

  • QMS Process Design

    Our team has significant expertise in QMS process design and can ensure you have all the required SOPs and WIs in place to pass audit inspection. Our approach helps you align your QMS and PV processes, ensures the PMSF is complete and audit-ready for all MAHs and assists with QPPV implementation and training for those marketing in Europe.

  • Technology Enablement

    We can help you select the most efficient technologies for your organisation, enabling a robust and compliant Global Safety Database integration, configuring a process for receiving regulatory intelligence and building a future-proofed and scalable solution.

  • Training and Education

    Our team can support you with your enterprise-wide training needs, ensuring all stakeholders are adequately trained in technology and processes, from your internal team to vendors and partners.

Don’t take our word for it

We’ve helped organisations across the globe to achieve a variety of strategic outcomes. From helping a leading medical device company to achieve financial outcomes and increase its share price to driving record performance for a luxury goods company, Explic8 has a proven track record.

Read Client Case Studies