CTIS Clinical Trial Regulatory Submissions in Europe
Sofpromed provides regulatory submission services via CTIS for clinical trials to be conducted in the European Union, including:
- Regulatory approval for clinical trials run in Spain, France, Germany, Italy, Poland, Czech Republic, Slovakia, and Greece, among other EU countries
- Creation and review of documents required for regulatory submission (protocol, Investigator’s Brochure, drug labels, etc.)
- Adaptation and translation of documents
- Preparation and review of submission package
- Completion of clinical trial application form
- Clinical trial application submission through the Clinical Trials Information System (CTIS)
- Responses to clarification requests and questions raised by regulators
- Phase I-IV clinical trials with drugs or medical devices in all therapeutic areas (oncology, cardiovascular, metabolic, central nervous system, dermatology, infectious and respiratory diseases, among others)
Please contact us if you need clinical trial regulatory submission services in Europe.