COMPREHENSIVE REGISTRATION SERVICES

New Drug Registration
End-to-end support for registering innovative pharmaceuticals and biological products across all EAEU member states.
Generic Drug Registration
Strategic pathway planning and dossier preparation for generic drug approval with optimized timelines.
Lifecycle Management

• Registration maintenance and renewals
• Post-approval variations and amendments
• License transfers and regulatory transfers

Our Registration Expertise
Strategic Registration Planning
We develop customized registration strategies that align with your business objectives and regulatory requirements across Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan.
Dossier Preparation & Submission

• Gap analysis of existing documentation
• Adaptation of international dossiers to EAEU requirements
• Comprehensive CTD/eCTD compilation
• Linguistic validation and professional translation

Procedure Management

• Selection of optimal registration procedure (national, mutual recognition, decentralized)
• Acting as your local regulatory representative
• Direct liaison with health authorities
• Timeline and milestone management

Why Choose Our Registration Services?
Proven Track Record
Successful registration of 50+ pharmaceutical products across the EAEU region.
Deep Regional Expertise
Up-to-date knowledge of evolving requirements in each member state.
Time-Efficient Approach
Average 30% reduction in registration timelines through optimized processes.
Risk Mitigation
Comprehensive regulatory intelligence minimizes approval delays.
Ready to begin your product registration?
Contact our SOLOREG regulatory team for a personalized consultation and timeline estimate.