GMP EAEU SOLUTIONS

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.