Tel / Fax: +38 (057) 759 02 41

Regulatory Support/Regulatory Submission

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.

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Contact Us

  • Tel / Fax: +38 (057) 759 02 41