Our Core Capabilities

Comprehensive, end-to-end regulatory affairs solutions designed for seamless market entry and post-market compliance.

medication

Pharmaceutical Product Registration

MANSAR Medical provides full-cycle regulatory support for pharmaceutical product registration.

  • check_circle New product registration
  • check_circle EAEU registration procedures
  • check_circle National registration procedures
  • check_circle CTD Dossier preparation & review
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biotech

Medical Device Registration

Regulatory support for medical device manufacturers entering Kazakhstan and EAEU markets.

  • check_circle Risk class assessment
  • check_circle Technical & clinical dossier
  • check_circle Testing coordination
  • check_circle Compliance support
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Regulatory Consulting & Lifecycle

Support throughout the entire product lifecycle.

  • check_circle Post-registration variations
  • check_circle Renewal procedures
  • check_circle Regulatory gap analysis
  • check_circle Authorized representative (MAH)
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health_and_safety

Pharmacovigilance Support

Robust safety monitoring and reporting systems designed to fulfill stringent local and regional obligations.

  • check_circle Outsourcing of QPPV functions
  • check_circle Construction & support of PV systems
  • check_circle Risk management system (RMS / RMP)
  • check_circle Preparation of PSMF & SOPs
  • check_circle Signal processing & reporting (PSUR, RMP, CIOMS)
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Preparing for Inspections (Inspection Readiness)

Full preparation for inspections according to GxP requirements by regulatory authorities and suppliers.

  • check_circle Preparation for GxP inspections (GMP, GDP, GVP)
  • check_circle Preparation for inspections by regulatory authorities & suppliers
  • check_circle Internal audits
  • check_circle Staff training & CAPA development

Regulatory Pathways & Scope Comparison

Regulatory Pathway Geographic Scope Est. Timeline Competent Authority
Kazakhstan National Registration Republic of Kazakhstan 7–12 Months NCEM (National Center for Expertise of Medicines)
EAEU Single Market (Mutual Recognition) Kazakhstan, Armenia, Belarus, Kyrgyzstan, Russia (5 States) 10–16 Months Eurasian Economic Commission & Reference State Authorities
Medical Device Conformity (EAEU) EAEU Member States 6–12 Months EAEU Designated Testing Laboratories & Ministries of Health
Pharmacovigilance (GVP EAEU) Local & Supranational Ongoing Lifecycle National PV Centers & EAEU Regulatory Agencies

Ready to Enter Kazakhstan & EAEU Markets?

Let our regulatory experts guide your product through every step of the registration and compliance process. Reach out today for a no-obligation consultation.

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