Solutions
Every plan needs strategic implementation
We provide flexible targeted solutions
Global Regulatory Operations
• Regulatory compliance design
• Regulatory operation and submissions
• Regulatory agency interaction
• Data Use permitting applications
• Ethical approvals and support
• EU representative services
• Medical Devices I-IV
• National market access/entry
• Healthtech and biotech regulation
Personal Data Protection
• GDPR assessment and compliance
• E-Privacy
• Data Use permitting
• Primary and secondary use data protection compliance
• EU representative
• EHR and patient management system compliance support
• HIPAA compliance
• EU AI Act compliance
Clinical and Pharmacovigilance operations
• Quality and pharmacovigilance oversight
• Health database analysis and interrogation
• AI support
• Data quality and utility labelling
• Study design and implementation
• Data Use permitting support
• Primary and secondary use support
• Regulatory submission support
Training
• Remote and in-person training
• EHDS compliance
• GDPR compliance
• EU regulatory environment
• HCP and HC provider training
• Bespoke training solutions
Project management
• Full EHDS compliance
• Key milestone check-ins
• EU and national market entry
• Cross-border compliance
• Health data quality
We also provide a full range of services in regulation, data privacy, PV and clinical trials and other studies.