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