Pharma studies
Submission support aligned to EU CTR, ICH-GCP expectations, and Czech country-level document requirements.
Regulatory services
- Clinical trial application planning and submission readiness review
- Country-specific document review and action tracking
- Substantial modifications, notifications, and response coordination
- Communication support with competent authorities and ethics committees
- Inspection and audit preparation support
- Medical device clinical documentation coordination where required
Authorities and frameworks
- SÚKL-facing support for Czech clinical trial processes
- EMA and CTIS coordination for EU CTR clinical trial workflows
- MDR and ISO 14155 alignment for medical device studies
- GDPR-aware handling of patient-facing and operational documentation
Medical devices
Practical coordination for MDR-facing activities and ISO 14155-aligned clinical documentation.
Lifecycle management
Support for RFIs, amendments, document updates, stakeholder coordination, and submission follow-up after initial filing.
Related submissions
Ethics committee submission support
CTIS support for EU submissions
Start-up links
Study start-up in Czechia
Study contract and budget negotiation support
Plan Czech regulatory support.
Use the contact form to describe submission timelines, involved countries, authority interactions, and documentation priorities.