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.