Regulatory Support and Trial Logistics
SPRI Ukraine has extensive experience with the procedures of the Ukrainian State Pharmacological Center and the Local Ethics Committees. Based on a clear understanding of both local and international regulations, we deal with regulatory support of clinical trials in Ukrainian Competent Authorities. Our SOPs have been carefully developed to ensure that all clinical trials are in compliance with local laws as well as with FDA and ICH guidelines. We offer logistical and customs support based on considered, valid and effective solutions which allow optimizing of study timelines as well as structuring and planning of study expenses in logistics. Our experience with Ukrainian customs authorities and clearance procedures enables us to efficiently manage the supply management process.