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
Law
Details

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


  • STEP ONE:

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

  • STEP TWO:

    Registration Dossier collection
    2.5-3 months

  • STEP TREE:

    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

  • STEP FOUR:

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