Preparation of your medicinal product documentation involves objective-based, scientific, and written documents to be compiled into a full dossier for submission. All pharmaceutical product data prepared must be composed following the specific national laws to be submitted.

Our experts can compose your dossiers in compliance with all local specifics that affect the registration and submission process and its progress. In particular, we provide services in the following actions of dossier preparation for submission:

  • Preparation of the dossier translations, where applicable
  • Preparation of local documents (SmPC/PIL, Normative document, package Artworks) in accordance with EAEU regulation)
  • Compilation of the dossier in accordance with EAEU requirements (M1 in paper copy)
  • XML formatting of the dossier in accordance with EAEU requirements, if requested

For any inquiry regarding our services, please contact Biomapas Business Development team.