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Registration of medicines and pharmaceutical substances

Регистрация лекарственных средств

Registration of medicines and pharmaceutical substances is a complicated and cumbersome process which demands intent attention. At this stage pharmproducers frequently have several difficulties in view of specificity of this not simple procedure. We are ready to take responsibility to execute all registration actions and also to provide your interests in Regulatory Bodies of RF.

 

We are happy to offer the complex set of services in the State registration of medicines and pharmaceutical substances:

  • consulting on the process of registration of medicines and pharmaceutical substances, drafting and confirmation of registration plan, every stage is prepared with thoroughness and analysis of potential possible complexities
  • if necessary to conduct preliminary trials of medicine samples
  • preparation of registration dossier, including the elaboration of normative documentation
  • preparation of document set for permission on clinical trials of medicines
  • preparing and providing documents for permission of authorized Federal Body and Federal Ethical committee
  • filling in electronic application and supply dossier at the Ministry of Health and Social Development of the Russian Federation
  • providing all registration process, preparing all necessary additional documents on requests of authorized Expert organization
  • receiving registration certificate

 

 

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