Ellion
Life-sciences focused consulting firm providing regulatory, quality, validation, process optimization and technology-enabled services across the pharmaceutical product lifecycle. Offers GxP training, audit and QMS assessments, digitalization support (CSV and data integrity), immersive XR training, and an internal incubator for prototype tools.
Industries
Nr. of Employees
small (1-50)
Ellion
Products
AI assistant for deviation management
AI-enabled tool designed to support deviation workflows in GMP environments by assisting with report drafting, risk assessments and root cause analysis.
AI assistant for deviation management
AI-enabled tool designed to support deviation workflows in GMP environments by assisting with report drafting, risk assessments and root cause analysis.
Services
Course covering process validation lifecycle from knowledge-based design to long-term performance monitoring and CPV integration; customizable format (in-person or remote).
Training on Stage 3 CPV covering definition/monitoring of critical process indicators and data-driven decision making.
GxP-focused CSV training covering lifecycle validation (GAMP 5) and ALCOA+ data integrity principles to mitigate computerized system risks.
Training to manage deviations end-to-end using structured investigation methods, compliant reporting and CAPA design/tracking.
PMO frameworks and tools tailored to regulatory-compliant project planning, monitoring, risk assessment and reporting.
Comprehensive audit methodology combining remote and on-site assessments to identify system and process improvements and readiness for accreditation or upgrades.
Course covering process validation lifecycle from knowledge-based design to long-term performance monitoring and CPV integration; customizable format (in-person or remote).
Training on Stage 3 CPV covering definition/monitoring of critical process indicators and data-driven decision making.
GxP-focused CSV training covering lifecycle validation (GAMP 5) and ALCOA+ data integrity principles to mitigate computerized system risks.
Training to manage deviations end-to-end using structured investigation methods, compliant reporting and CAPA design/tracking.
PMO frameworks and tools tailored to regulatory-compliant project planning, monitoring, risk assessment and reporting.
Comprehensive audit methodology combining remote and on-site assessments to identify system and process improvements and readiness for accreditation or upgrades.
Expertise Areas
- Regulatory compliance and GxP
- Process validation and PPQ
- Continued Process Verification (CPV)
- Computer system validation and data integrity
Key Technologies
- XR/VR immersive training
- AI-driven deviation assistance
- Industry 4.0 process automation
- Computer system validation (GAMP 5)
News & Updates
Claims over 500 years of combined team experience.
States 30+ customers served in EMEA and US regions.
States 220+ projects successfully delivered.
Claims over 500 years of combined team experience.
States 30+ customers served in EMEA and US regions.
States 220+ projects successfully delivered.