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  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica

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Registration of generics in Russia

We combine 20 years European background with deep local insight in Russia….

Located in Central Europe, in addition to English, our Czech team is fluent also in Russian, what together with full comprehension of European, US and Russian requirements namely in GxP, analytics, bioavailability / bioequivalence (BA/BE) and long term experience in these areas makes our services competitive.

Since 2010 Quinta have conducted or participated at more than 25 bioequivalence studies in Russia. We have a joint-venture company located in Russia owning BA/BE clinical site with 44 beds and in addition to our Prague laboratory we have a joint-venture bioanalytical laboratory located in Russia. Our Russian joint-venture company works according to our own European working procedures adjusted to current Russian legislation. We permanently supervise and improve performance our Russian partners. Also we co-operate with partner Russian sites for preclinical studies in generics (required now by Russian Law) and have sound comprehension of Russian regulatory strategy in generics in general.

Quinta offers a comprehensive set of services to the companies targeting Russian generic market. Whether you are looking for assistance with regulatory submissions in Russia, preclinical studies in generics or require a full range of bioavailability/bioequivalence (BA/BE) clinical and bioanalytical services, our R&D professionals, regulatory and medical team can provide you with all support you need.

What we offer in Russia (all services available in English and Russian languages):

  • Development hypothesis and milestone evaluation in BA/BE area
  • Type of study (e.g. 2 way, fully replicated, two stage etc.) in line with current Russian guidelines
  • Calculation of sample size, variability estimation, blood sampling optimization, study population
  • Selection of clinical site for BA/BE study in Russia
  • Development support (treatment difference estimation using in vitro data)
  • Own in-house pharmacokinetics and statistical expertize (over 350 data sets, molecules)
  • Cost effective solutions (CRO tendering and qualification), full BA/BE study management
  • Import of drugs, export of plasma samples
  • Russian LEC approval
  • Full clinical management, monitoring, quality assurance
  • Bioanalytics and statistics
  • Medical Writing also in Russian
  • Compilation of Final Report in Russian
  • Regulatory Strategy consultancy in Russia
  • Quality Assurance, GMP, GCP, GLP

Legal background

In September 2010, the new Federal Law number 61 "On Circulation of Medicines" came into force in the Russian Federation. This law has introduced a number of changes to the system of registration of medicines. One of the most significant changes is general requirement of Russian bioavailability / bioequivalence studies for all newly registered drugs for oral administration. This requirement led to significant changes in the field of clinical trials in Russia: Since 2010, the requirement for own Russian bioequivalence studies applies also to foreign companies no matter if they have already conducted these studies with the same drug, for example the EU, Canada or the United States. Even if the reference drug is a global drug registered in the EU, the U.S. or other countries, and its first bioequivalence study was conducted in EU, Canada, the U.S. etc. with the same global original drug as a reference, the study should be repeated in the Russian Federation.