Registration dossier is a set of documents that contain a detailed information on the drug.

In Russian Federation registration dossier is necessary for the authorization of a drug product, drug substance, variations.

The contents of the dossier vary depending on its purpose. For variations the dossier is smaller than it is for oroginal authorization of a drug.

We will help you prepare the registration dossier according to the requirements of Federal Law No. 61-ФЗ "On drugs". It will contain all the necessary documents for drug authorization including: regulatory documentation, prescribing information, package designs.

A detailed List of documents for medical products authorization in Russia