Clinical Trial Regulatory Submissions in Georgia

Sofpromed provides regulatory submission services for clinical trials to be conducted in Georgia, including:

• Creation and review of documents required for regulatory submission (protocol, Investigator’s Brochure, drug labels, etc.)
• Adaptation and translation of documents according to local requirements
• Preparation and review of submission package
• Completion of clinical trial application form
• Clinical trial application submission to the State Regulation Agency for Medical Activities (LEPL) of the Ministry of Labor, Health, and Social Affairs 
• Responses to clarification requests and questions raised by LEPL
• 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 Georgia.