Service: "Turnkey Submission to the Ministry of Health (close part DMF/MFAFS) in Compliance with New EAEU Requirements"
We offer a comprehensive service for the preparation and submission of a Drug Master File (DMF) to the Ministry of Health (MFAFS) in accordance with the new EAEU requirements. We provide full end-to-end support throughout the entire process.

What’s included in the service?
Regulatory Requirements Analysis

Verification of documentation compliance with current EAEU standards.

Identification of required DMF sections.

Preparation of the Drug Master File (DMF)

Compilation of a complete submission package in line with the Ministry of Health’s checklist requirements.

Documentation Adaptation to EAEU Standards

Alignment with EAEU TR 038/2021 (GMP) and EAEU TR 041/2017 (drug safety).

Translation services (if required).

Interaction with the Ministry of Health (MFAFS)

Submission of documents in electronic and paper formats.

Responses to regulator inquiries.

DMF adjustments based on feedback.

Legal Support

Regulatory compliance consultations.

Expedited Submission Process

Minimizing rejection risks through preliminary review.

Why Choose Us?
Proven track record of successful submissions in Russia, Kazakhstan, Belarus, and other EAEU countries.
In-house database of templates & experts in GMP, pharmacovigilance, and CMC.
Full turnkey support – saving you time and resources.

Ready to get started? Submit your request, and we’ll prepare a customized DMF submission plan!