The GCC is harmonizing regulations with the EAEU. Soon, we will open our office in the GCC to accelerate the simplified registration process for pharmaceuticals in GCC and EAEU countries.

At SoloReg, we offer expert support for pharmaceutical, veterinary, and dietary supplement manufacturers to achieve GMP certification in Russia and the Eurasian Economic Union (EAEU). Our services ensure seamless navigation through inspections and regulatory processes.

GMP Pre-Audit / GAP Analysis We assess your site's readiness for Russian or EAEU GMP compliance before application submission. Goal: Identify discrepancies early to avoid issues during inspection. Format: On-site or remote (via documentation and video). Includes: Detailed inspection report classifying non-conformities (critical, major, minor) and recommendations for Corrective and Preventive Actions (CAPA).
Preparation and Submission of Application Dossier We compile and submit a full set of documents for GMP inspection to authorities like Russia's Ministry of Industry and Trade, Roszdravnadzor, or EAEU regulatory bodies. Includes: Application forms, dossier verification (Site Master File, product lists, normative documents), translations/apostilles if needed, and ongoing interaction with regulators until inspection scheduling.
GMP Inspection Support Remote or on-site assistance during inspections to boost success rates. Includes: Qualified interpreters with GMP expertise, communication facilitation between staff and inspectors, session monitoring for remote formats, and help responding to inspector queries. Goal: Achieve a positive inspection outcome through transparency and preparation.
CAPA Plan Development and Review If non-conformities arise during inspection, we analyze and classify them, assist in creating a CAPA plan, monitor implementation, and prepare responses to health authorities if required. Focus: Effective corrective and preventive measures to resolve issues promptly.
Consulting and Support for Re-Submission / Secondary GMP Inspection For negative outcomes or planned re-applications, we analyze prior non-conformities, update documentation, and guide the secondary submission cycle to ensure compliance and successful re-inspection.
Personnel Training Individual or group sessions on EAEU GMP inspection specifics, including organizational aspects, personnel behavior during audits, and customized webinars from leading GMP experts to enhance team readiness.

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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

SOLOREG provides a full range of services for the introduction and sale of foreign-made medicinal products to the Russian market.

THE SERVICE INCLUDES:

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. Office incorporation
6. Import of medicinal products to the territory of the Russian Federation and customs clearance
7. Implementation of procedures for entering into civil circulation
8. Accumulation, storage, distribution and sale of medicinal products
9. 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