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:
- STEP ONE:
Approval for Clinical Trial obtained.
Clinical trial conducted
Clinical trial's duration
- STEP TWO:
Registration Dossier collection
- 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.
- STEP FOUR:
Decision of the inclusion of the drug into the State Register of Medicine made. Drug Product Registration Certificate issued.