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our expertise

At the heart of our operations is our focus on quality.

We believe in offering creative, innovative ideas and provide a service of excellence to all our customers.

Core Pharmacovigilance Provisions

  • EU QPPV/Deputy EU QPPV services
  • Pre and post marketing case management (including submissions)
  • Literature screening and review
  • Routine safety surveillance and signal detection
  • Periodic Report scheduling, production and submission
  • Risk Management Plans production and tracking of implementation
  • Pharmacovigilance System Master File (PSMF) preparation and maintenance
  • Drafting, reviewing, negotiating and maintaining Safety Data Exchange Agreements (SDEA)

    - including extended work with Quality Assurance, Business Development and Legal teams regarding link to Technical Agreements and Commercial contracts