Regulatory Support
End-to-end regulatory services: registration, pricing, inclusion in national lists, and compliance across EAEU.
Marketing & Market Access
From formulary access to commercialization: insights, approvals, education, and tender intelligence.
Distribution
GDP-compliant supply chain, quality & safety control, and coordinated promo-material approvals.
Medical Device Registration
End-to-end registration of medical devices in Kazakhstan by a dedicated specialist: from classification to post-market oversight.
Medical Device Registration
Classification & Strategy
Device class determination, route selection, and regulatory roadmap per EAEU/KZ rules.
Dossier Preparation
Technical file, safety/efficacy data, labeling and IFU alignment, localization as required.
Conformity Assessment
Coordination with notified bodies, testing, clinical evaluation reports, and QMS evidence.
State Registration
Submission to the competent authority, communication, responses to queries, certificate issuance.
Post-Market Surveillance
Vigilance, incident reporting, field safety notices, and ongoing regulatory compliance.