Registration, Marketing Support & Market Access for Manufacturers of Pharma, Herbals, Nutraceuticals & Vet Drugs in Russia/EAEU

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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!

SOLOREG HAS SOLID EXPERIENCE IN PROVIDING THE FOLLOWING SERVICES:

• Registration of medicines
• Registration of veterinary drugs
• Registration of cosmetics
• Registration of herbal medicines
• Registration of biologically active supplements (BAS)
• Registration and re-registration of prices for drugs
• Preparation and submission of documents for obtaining a GMP certificate
• Conducting independent audits of drug production facilities and preparing for them
• ​​Bringing registration dossiers into compliance with the requirements of the EAEU
• Amending documents for registered medicines
• Confirmation of state registration
• Technical conversion of the dossier into XML format (electronic dossier)
• Consulting services on regulatory issues and intellectual property issues

Since 2022, SOLOREG has been organizing and conducting all types of clinical trials, including:

• Phase I-IV clinical trials for original drugs
• Bioequivalence and therapeutic equivalence studies for generics

In addition, the company provides services for:

• Conducting independent audits of clinical trials
• Preparation for inspections by regulatory authorities
• Developing a strategy for registration clinical trials

In the field of pre-clinical research, SOLOREG:
Cooperates with leading domestic laboratories
Conducts audits of laboratories in accordance with the standards of good laboratory practice
Helps develop an optimal research program
Organizes research data for our clients

In cooperation with our partners, SOLOREG provides a full range of services for the introduction and sale of foreign-made medicinal products to the Russian market.

THE SERVICE INCLUDES:
REGISTRATION STAGE

1. Marketing research
2. Organization and implementation of preclinical and clinical trials of medicinal products
3. Implementation of the necessary registration procedures for the medicinal product
4. Registration of the owner, manufacturer and the medicinal product itself in the drug flow monitoring system
5. Import of medicinal products to the territory of the Russian Federation and customs clearance
6. Implementation of procedures for entering into civil circulation
7. Accumulation, storage, distribution and sale of medicinal products
8. Implementation of pharmacovigilance

If the results of the joint marketing analysis conducted with SOLOREG partners confirm sufficient economic potential of the product, joint financing of the project is possible