Regulatory Affairs and Pharmacovigilance

Blueclinical provides comprehensive regulatory and pharmacovigilance services from the early stage of development through to marketing of your medicinal products and medical devices.

Blueclinical has a well-trained staff in regulatory pharmacovigilance services, including European Qualified Person for Pharmacovigilance (EU-QPPV).

Our regulatory and pharmacovigilance experts are supported by Blueclinical’s clinical experts, who include physicians covering a wide range of medical specialties.

Our services include:

Pre-marketing:

  • SAE/SUSAR management
  • DSUR
  • Safety review
  • Safety database management
  • Preparation and/or review of safety documentation
  • Preparation of non-clinical and clinical overviews and other regulatory documents

Post-marketing:

  • EU-QPPV
  • Local contact point/QPPV deputation
  • Full Pharmacovigilance system management
  • Handling, management and submission of ICSR
  • Medical and scientific literature monitoring
  • Post-Marketing Periodic Reports
  • Risk Management Plans and Risk Minimization Measures
  • Pharmacovigilance System Master File
  • Pharmacovigilance System summary
  • Global safety database management
  • Safety Data Exchange Agreement
  • Regulatory Intelligence
  • Preparation and submission of Safety variations
  • Eudravigilance registry and maintenance
  • Signal monitoring and detection
  • MedDRA coding