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Regulatory Competence for Russian Federation and CIS


In cooperation with hand-picked local and international partners we offer services for pharmaceutical companies in the following areas:

  • New registration and maintenance of registrations of medicinal products and medical devices in Russian Federation; CIS and EAEU region

  • Upgrade procedures for EAEU region

  • Definition of registration strategies

  • GMP inspections by Russian/EAEU authorities

  • Consultancy for local bioequivalence studies (audits; monitoring; preparations)

  • Local toxicological studies

  • Due diligence of registration dossiers