Services
Regulatory
Regulatory Authority and Ethics Committee submissions
- Preparation of complete packages for the Regulatory Authorities and Ethics Committees
- Advice to Sponsor on specific local requirements for submission documents
- SanaClis expertise of study documents provided by Sponsor/other parties involved
- Translation of documents according to local requirements
- Application to the national Regulatory Authority and Ethics Committees
- Submission to RA & ECs and advise on review timelines / meeting dates
- Updates of requirements
- Clarification of requirements – interface between sponsor and RA/EC (local)
- Obtaining and check / translation of approvals
Regular contacts with RA/EC throughout the study
- Compliance with international and local reporting requirements
- Follow-up submissions
- Notifications
Import/Export licenses/permits
Certifications by local bodies (if applicable)
SanaClis regulatory specialists attend regularly advisory sessions and seminars organized by RA and RA experts to be up-to-date in changing regulatory environment.
We are hiring

placeGLOBAL
Business Development
placeCENTRAL & EASTERN EUROPE
Clinical Research Associate for Czech Republic, Prague
Clinical Research Associate
Project Manager
Clinical Data Manager
SAS programmer and Senior Statistician position
placeSLOVAKIA & UKRAINE
Logistic Coordinator
Warehouse Manager & Assistant
This website uses cookies. By using and further navigating this website you accept this.