Preparation of Regulatory Dossier
Services for Document Preparation for the Dossier:

  • State Registration
  • Confirmation of State Registration
  • Amendments to Documents for Registered Medicinal Products
  • Development of Regulatory Documentation (Specifications, IMP, textual content of packaging mock-ups, package inserts, and quality control documentation).
  • Preparation of literature references, overviews, and writing registration modules 2.2-2.7 in accordance with EAEU regulations.
  • Preparation of documents and conducting user testing of the package insert.
Moscow, 117105, Varshavskoye Highway, Building 1, Block 6.
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