Mikhailyuk, Sorokolat & Partners

Patent and Trademark Attorneys

Comprehensive support for eCTD dossier submission

July 01, 2025

Starting August 18, 2025, the submission of registration dossiers for medicinal products in eCTD format will become mandatory in Ukraine — aligning the country with international digital standards already in use in the EU, USA, and beyond.

We offer:

  • Full support in preparing and submitting eCTD dossiers
  • Expert consultations and regulatory guidance
  • Proprietary eCTD software (ICH eCTD v3.2.2 & Module 1UA compliant)
  • Tools for dossier structuring, validation, and lifecycle management
  • Read more via the link.

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