Pharmaceutical Regulatory Affairs in Russia
We provide the following services for registration of medicines in Russia, EAEU, CIS:
1. Overview of preclinical and clinical studies according to the EAEU requirements (module 2.4-2.7)
2. Development of a draft regulatory documentation (normative document) in accordance with the EAEU requirement
3. Draft instructions for medical use or General characteristics of the medicine (summary of product characteristics)
4. Development of a package leaflet and Custom testing of the package leaflet text
5. Registration dossier preparation: Preparation of dossiers according to the EAEU requirements (OTD format). Dossier coding in xml format.
6. Consultations, preparation of responses to authorities’ requests during the expertise period in order to obtain a registration certificate of the medicine
7. Registration dossier validation
8. Translation of specialized medical, chemical, pharmaceutical documentation
9. Support of the registration process
10. Organization of the comparative dissolution kinetics test
11. The GMP EAEU inspection:
- Preparation and submission of an application for GMP inspection of the manufacture site for compliance with the GMP EAEU rules
- verification of documents for GMP inspection;
- translation, notarization of documents;
- advising on requests for submitted documents before the inspection;
- GMP pre-audit of the manufacture site
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