Validated Notilyze Cloud

Validated Notilyze Cloud is a GxP-compliant cloud infrastructure service from Notilyze, designed for organizations operating in regulated life sciences sectors including Biotech, Pharma, and Medtech. Hosted in Amsterdam, Europe, the platform is built to meet regulatory requirements around security, validation, and data sovereignty, giving organizations control over sensitive clinical and research data while maintaining alignment with GxP, GDPR, and related regulatory frameworks.

The service targets organizations across clinical development, biostatistics, data management, regulatory submissions, medical devices, digital health, and real-world data analytics. It is designed to scale from early-stage biotech startups through to large commercial organizations with global operations.

Core Capabilities

• Validated GxP cloud infrastructure aligned with current regulatory expectations
• Full European data sovereignty with infrastructure hosted in Amsterdam
• Secure, compliant, and audit-ready environment designed to support inspections by regulatory authorities and institutional auditors
• Scalable compute resources for clinical and research workloads
• Validation documentation and implementation support
• Managed security, backup, and monitoring services
• Regulatory-aligned operational processes

Compliance and Audit Readiness

• Infrastructure, documentation, and processes are designed to support regulatory authority inspections and institutional audits
• Consistent track record of supporting successful audits in regulated environments
• Operations aligned with GxP and GDPR requirements

Supported Use Cases

• Clinical development workflows
• Biostatistics and data management
• Regulatory and submission workflows
• Medical device and digital health applications
• Real-world data and research analytics

Professional Services and Support

• Validation specialists with experience in regulated environments guide customers through implementation, validation, and ongoing operation
• Consultation available with experienced life sciences professionals, including expertise in data management, clinical research, and analytics
• Notilyze manages the validated cloud environment, security, and compliance operations on behalf of customer organizations

Notilyze B.V. is headquartered in Rotterdam, Netherlands. Organizations seeking to deploy regulated workloads in a validated European cloud environment can contact Notilyze directly to schedule a consultation or request further information about implementation and compliance support.