Eurasian Economic Union (EAEU) has combined various national variations of dossier materials and submission specifications into one system for all countries in this region. We provide the following services:
- Evaluation of current dossier national variations regarding the Revalidation procedure
- Evaluation of Eurasian Economic Union dossier variations regarding the Revalidation procedure
- Amendment of pre-RVP and EAEU dossier variations for compliance with EAEU regulation specifications
- Preparation of the dossier materials according to the national or EAEU requirements:
- Summary of Product Characteristics (SmPC)
- Patient Information Leaflets (PILs)
- Normative Documents (ND)
- Packaging Artworks (AWs)
- Submission and procedure maintenance
Biomapas provides full procedure management for all national and Eurasian Economic Union region dossier variations in accordance with the requirements including preparation of the submission strategy.
For any inquiry regarding our services, please contact Biomapas Business Development team.