• QPPV Services
• EudraVigilance
• SPOR
• PSMF

• SAE & SUSAR Management
• ART 57 (xEVMPD)
• ICSR Case Management
• Literature Monitoring

• Signal Detection & Management
• Benefit-Risk Management - RMP, REMS
• Drug Safety Physician Service

• Aggregate Reports

• Drug Safety Database
• Case Migration Service

• Drug Safety & Reporting Training
• Responsible Person Services
• Safety Management Plan
• CT Documentation Development
• SAE & SUSAR Management

• LPPV & Local Safety Officer
• Local ICSR Management
• Local Literature Monitoring
• Regulatory Intelligence
• EU-QPPV & LPPV – Country Search

• Regulatory Intelligence

• Non-Clinical & Clinical Development Consultancy
• Regulatory Strategy
• Gap Analysis
• Dossier Development
• Scientific Advice – Protocol Assistance
• Paediatric Investigation Plans
• Orphan Drug Designation
• SME Application
• Regulatory Due Diligence

• Clinical Trial Regulatory
• Marketing Authorization Applications
• Lifecycle Management
• Marketing Authorization Transfers
• CMC & Medical Writing

• Dossier Publishing
• Artwork & Labeling
• Linguistic Review & Translations
• Readability & User Testing

• Commercialization Readiness
• Quality Outsourcing – Responsible Person/Qualified Person
• Supply Chain Mapping & GDP

• GxP Audits
• Mock Regulatory Inspection
• QP Audits
• Regulatory Inspection Readiness & Support
• Vendor/Supplier Audit Program Management

• GxP Issue Resolution
• Quality Risk Management
• Quality Technical Services

• QMS/PQS