SPRI Ukraine offers regulatory support in Competent Authorities in Ukraine basing on a clear understanding of both local and international regulatory requirements:

• Regulatory consulting;
• Preparation of clinical trial submission documents for obtaining an approval to perform the clinical trial in the Ministry of Health of Ukraine;
• Approval of the Local Ethics Committees;
• Approval in the committees for DRUG contained narcotic precursors;
• Insurance for participants of the trial;
• Project and negotiation of contracts with the research center and investigators in compliance with the Sponsor's request and current legislation;
• Obtaining import and export licenses for investigational products;
• Translation services, including back translation and proofreading;
• Reporting to the local regulatory authorities;
• Obtaining quality certificate of imported medical devices.