Expert Regulatory Guidance for Entry into CIS Pharmaceutical Markets
The Commonwealth of Independent States (CIS) region, comprising former Soviet Republics, presents significant opportunities for pharmaceutical companies. However, the regulatory environment across countries like Russia, Kazakhstan, Ukraine, Uzbekistan, and others is evolving and highly localized, requiring in-depth knowledge of language, processes, and documentation formats.
RABT Global offers tailored Regulatory Services for Pharmaceuticals across the CIS region to help you achieve seamless product registration, compliance, and market entry—backed by a team that understands the intricacies of local regulations and industry expectations.
Our Services Include:
1. Regulatory Strategy & Market Access
Country-specific regulatory pathway development
Local classification of medicinal products
Dossier requirements, timelines, and approval forecasts
Eurasian Economic Union (EAEU) regulatory integration planning
2. Dossier Preparation & Product Registration
Preparation of dossiers in CTD/eCTD format with country-specific modifications
Translation into Russian and local languages as required
Submissions to national authorities such as:
Ministry of Health of Russia (MoH RF)
Kazakhstan (NDDA or MoH)
Uzbekistan (Minzdrav)
Belarus, Armenia, Kyrgyzstan, and other CIS markets
Handling registration renewals, variations, and supplementary applications
3. GMP and Manufacturing Site Compliance
Assistance with GMP inspections and certification processes
Coordination with authorized inspection bodies or agencies
Document preparation, audit support, and regulatory follow-up
4. Local Representation & Agent Support
Appointment and management of local agents and authorized representatives
Regulatory and legal liaison with health authorities and industry bodies
5. Labeling & Packaging Compliance
Regulatory review of labeling and leaflets according to regional language and format standards
Validation of packaging components with local guidelines
6. Pharmacovigilance & Post-Market Monitoring
Setup of local pharmacovigilance systems and QPPV support
Adverse event reporting, risk management, and safety updates
Ongoing compliance with post-market requirements across CIS countries
Countries We Support in the CIS Region
Russia
Kazakhstan
Uzbekistan
Ukraine
Belarus
Armenia
Kyrgyzstan
Azerbaijan
Georgia
Tajikistan, Turkmenistan, and other neighboring territories
Why Choose RABT Global?
Multilingual Regulatory Expertise for Russian-speaking markets
Deep Understanding of CIS healthcare systems and authority protocols
Established Local Partnerships with in-country consultants and agencies
Proven Record in handling complex product submissions and approvals
Start Your CIS Market Journey
Need to register your pharmaceutical products in Russia or other CIS countries?
RABT Global ensures a clear, compliant, and timely pathway to market approval.
