OCT offers regulatory support for clinical trials in Russia, Ukraine, Bulgaria, and Baltic States:
- Final approval to carry out clinical research in the Ministry of Health;
- Approval to carry out trials in the center for medication examination and pharmacologic committee;
- Approval in the national committee for ethics;
- Approval in the local committees for ethics;
- Approval in the committees for narcotic drugs;
- Insurance for participants of the trial;
- Design and negotiation of contracts with clinics, where clinical and pharmaceutical research is performed;
- Design and negotiation of contracts with investigators;
- Obtaining permissions of the customs committee to import/export investigative product (IP), biologic specimens and medical equipment;
- Obtaining permissions to destroy remaining IP;
- Certification of imported equipment;
- Translation services, including back translation and proofreading;
- Recommendations on cargo marking, corrections;
- Reporting to the local regulatory bodies;
- Licensing research centers, as necessary;
- Providing marketing and analytical materials on Clinical Trials in Eastern Europe.
| Russia | Ukraine | Baltic States | Bulgaria |
| 3 months to obtain approval for conducting a study from regulatory authorities. 1 week to obtain import license | 3 months to obtain approval for conducting a study from regulatory authorities. 1-2 days to obtain import license | 1.5 months to obtain approval for conducting a study from regulatory authorities. 1-2 days to obtain import license | 2 months to obtain approval for conducting a study from regulatory authorities. 1 week to obtain import license |
Sponsor-oriented and quality service is our priority.
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