verified Kazakhstan & EAEU Certified Experts

Regulatory Affairs
Solutions for Pharmaceuticals,
Medical Devices, and Dietary Supplements

Professional regulatory support for product registration, compliance, and market access across Kazakhstan and the broader EAEU. We navigate complexity so your products reach patients safely.

100%
Submission Accuracy
5+
EAEU Markets
GxP
Compliant Process
MANSAR Medical regulatory affairs consulting team presenting compliance strategy
public EAEU Authorized
science GxP Compliant
verified Kazakhstan Registered
health_and_safety PV Support
workspace_premium Expert Consultants
public EAEU Authorized
science GxP Compliant
verified Kazakhstan Registered
health_and_safety PV Support
workspace_premium Expert Consultants
Professional regulatory compliance team reviewing pharmaceutical documents Advanced medical devices on clinical surface

Navigating Regulatory Complexity with Authority

MANSAR Medical provides end-to-end regulatory affairs solutions for pharmaceutical and medical device companies seeking access to Kazakhstan and EAEU markets. We translate complex institutional guidelines into clear, actionable compliance pathways.

all_inclusive

Full Lifecycle Support

From pre-submission strategy through post-market surveillance, we cover every regulatory touchpoint.

Local + EAEU Expertise

Deep knowledge of Kazakhstan national regulations and unified supranational EAEU protocols.

schedule

Efficient Management

Streamlined project execution designed to accelerate regulatory approvals and minimize delays.

gavel

Legal Representation

Serving as your authorized local representative and Marketing Authorization Holder (MAH).

Our Service Offerings

Specialized regulatory capabilities designed to secure and maintain product compliance across all relevant jurisdictions.

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 Registration recognition procedures
  • check_circle Registration dossier preparation and review
  • check_circle Preparation of responses to regulatory authority questions
  • check_circle Regulatory strategy development
biotech

Medical Device Registration

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

  • check_circle Registration support
  • check_circle Regulatory documentation preparation
  • check_circle Regulatory pathway assessment
  • check_circle Communication with regulatory authorities
  • check_circle Compliance support
account_tree

Regulatory Consulting & Lifecycle Management

Support throughout the entire product lifecycle.

  • check_circle Post-registration variations
  • check_circle Registration dossier updates
  • check_circle Renewal procedures
  • check_circle Regulatory gap analysis
  • check_circle Regulatory documentation review
  • check_circle Regulatory strategy support
health_and_safety

Pharmacovigilance Support

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

  • 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)
verified

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

Precision at Every Step

World-class facilities, expert consultants, and cutting-edge tools dedicated to your regulatory success.

MANSAR Medical regulatory strategy team reviewing compliance documents in Almaty
Regulatory Strategy
Expert Advisory & Compliance Solutions
Pharmaceutical research environment adhering to GxP compliance standards
Inspection Readiness
GxP Quality & Compliance Standards
EAEU regional network map with Kazakhstan highlighted
Market Access
EAEU Regional Reach
Advanced medical devices on clinical surface
Medical Devices
Device Registration Expertise

Why Partner with MANSAR Medical

Delivering regulatory excellence through international project experience, flexibility, and transparent processes.

public

Experience with International Projects

Proven track record managing complex regulatory submissions for global pharmaceutical and medtech manufacturers.

tune

Flexible Approach to Client Needs

Tailored, personalized regulatory strategies customized to your unique product portfolio and business priorities.

groups

Professional Team

A dedicated team of senior regulatory affairs, GxP inspection readiness, and pharmacovigilance experts.

schedule

Clear Deadlines & Transparent Processes

Clear milestones, predictable timelines, and transparent workflow reporting at every stage.

Request a Consultation

Have questions about regulatory requirements? Our team is ready to assist you with product registration, compliance, and market access in Kazakhstan and EAEU.

call
location_on

Office Address

261 Turgut Ozal Street, Almaty 050060, Republic of Kazakhstan

Send Us a Message

Fill out the form below and we will get back to you shortly.

This field is required
Please enter a valid email address
This field is required
check_circle

Message Sent!

Thank you for reaching out. Our team will review your inquiry and get back to you within 1–2 business days.

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.