Medicine registration

The final stage of the drug development process is the registration of the drug. Our team offers a full range of high-quality services for government registration in Russia for both domestic and foreign sponsors

Our support includes:

  • Collection and preparation of documents needed to apply for registration of a drug in accordance with the demands of Russian legislation
  • Preparation of a set of documents needed for registrations: administrative documents, description of pharmaceutical properties, technological data, information about the pre-clinical and clinical studies of the drug
  • Submission of the set of registration documents to the Ministry of Health of the Russian Federation
  • Qualified support and cooperation with regulatory authorities, processing of official enquiries and letters
  • Obtaining and providing the client with a certificate of registration in the Russian Federation

The process and timelines of drug registration in Russia can be described as follows:


    Approval for Clinical Trial obtained.
    Clinical trial conducted
    Clinical trial's duration


    Registration Dossier collection
    2.5-3 months


    Submission of the dossier with the results of clinical studies in the Ministry of Health, the examination of the registration dossier for the drug.
    5.5 months


    Decision of the inclusion of the drug into the State Register of Medicine made. Drug Product Registration Certificate issued.
    3 months