Russia Market Entry
We help international companies identify applicable Russian regulatory requirements and determine the
appropriate pathway for market entry
Product Registration
We support registration of medical devices and other regulated products, including regulatory assessment,
classification, dossier preparation, submission, and authority coordination
Certification & Compliance
We coordinate product certification, declarations of conformity, testing, and other applicable Russian
compliance requirements
Testing & Localization
We coordinate technical, toxicological, biological, and clinical testing, as applicable, together with
Russian labeling, translations, and technical documentation
Quality & Audit Support
We support QMS readiness, manufacturing-site inspections, ISO 13485 documentation review, mock audits,
CAPA planning, and inspection follow-up
Other Services
We provide regulatory lifecycle management, registration amendments, local representation, licensing and
permits, post-market support, and ongoing regulatory compliance