Since coming into force of the Federal law of the Russian Federation ФЗ-61 dated April 12, 2010 "About Pharmaceuticals Circulation" the process of "registration" of pharmaceutical substances was altered for "entry of pharmaceutical substances into the register of medicines". As per its structure this process has no difference from registration, except for specific provisions. One of such features is the so called entry of pharmaceutical substances into the register in the process of registration of the medicine within which this substance is used.
Our services on registration of pharmaceutical substances are as follows:
- Assessment of the primary dossier
- Request for missing documents, if necessary, in accordance with ФЗ-61
- Document translation
- Preparation of drafts of documents / manufacturer's monographs, models
- Collection and formation of the registration file
- Filing the dossier to the Ministry of Healthcare
- Presentation of samples for PhE (pharmaceutical expertise)
- Expertise support
- Entry of the substance into the state register
Our company will help to enter your substance into the register or give you advice about the documents which you should request from the manufacturer of the pharmaceutical substance used in your medicine.
- Pharmacoeconomic studies
- Development of medical documentation
- Medical statistics and translations