Unified Element | Soloreg Advantage | What You Gain |
One Registration Dossier | Compile and submit a single, compliant dossier tailored to EAEU standards, covering all necessary data for seamless evaluation. | Immediate access to regulatory review across all 5 EAEU countries, avoiding multiple submissions. |
One Registration Process | Navigate a harmonized procedure across the EAEU, reducing timelines and bureaucratic hurdles. | Faster approvals without redundant national processes, accelerating your market launch in the entire union. |
One Pharmaceutical Expertise of Samples | Conduct expert sample analysis once, ensuring quality and compliance meet regional requirements. | Single validation that applies union-wide, saving costs and time on repeated testing. |
One Registration Certificate | Obtain a unified certificate valid throughout the EAEU, eliminating the need for separate national approvals. | One certificate unlocks sales and distribution in Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan simultaneously. |
One GMP Certificate | Secure a single EAEU GMP certification, applicable union-wide, with our support in inspections and documentation. | Broad compliance recognition, enabling production and supply chain efficiency across 5 markets. |
One Set of Clinical Studies | Utilize shared clinical data recognition, minimizing additional trials for faster validation. | Efficient data leverage for union-wide acceptance, reducing R&D expenses and speeding up entry to over 180 million consumers. |
