Related support
Regulatory affairs in Czechia
CTIS support for EU clinical trials
Ethics submission services
- Preparation and quality review of submission dossiers
- Coordination of ethics committee communication and follow-up responses
- Alignment with sponsor, CRO, and site stakeholders
- Tracking approval milestones and documentation updates
- Support for CTIS Part II country-specific documentation
- Experience across pharmaceutical, medical device, and post-market studies
Documentation support
- Informed consent forms and patient-facing materials
- Study protocols, investigator documentation, and local site forms
- Country-specific language and completeness review
- Consistency checks across submission packages and operational documents
- Support for combined drug and medical device programs, including drug-device combinations and five drug-IVD/CDx combinations
Start-up and site readiness
Study start-up in Czechia
Study contract and budget negotiation support
Coordinate Czech ethics submissions.
Use the contact form to share the study context, planned timelines, site model, and submission package status for pharmaceutical, medical device, post-market, or drug-device combination studies.