Regulatory Support
End-to-end regulatory services: registration, pricing, inclusion in national lists, and compliance across EAEU.
Regulatory Services
AYAZ PHARM ensures access to high-quality medicines, dietary supplements, and medical devices through regulatory expertise, market access strategy, and GDP-compliant distribution.
Discover Our Services
Regulatory Support
Registration, compliance, pricing
Distribution
GDP-compliant supply chain
Our Services for
Pharma & MedTech
Regulatory Support
- Drug Registration & Protocol Inclusion
- Pricing & Caps (GOBMP) Registration
- ALO / GOBMP / ED Lists Support
Custom
Marketing & Market Access
- National Formulary & Treatment Protocols
- Hospital & Ambulatory Lists
- Access Analysis (GOBMP / OSMS)
Custom
Medical Device Registration
- Classification & Regulatory Strategy
- Dossier Preparation & Localization
- State Registration & Post-Market Surveillance
Custom
Why Choose AYAZ PHARM
Trusted by Pharma & MedTech Partners
End-to-end support in Kazakhstan: regulatory, market access, device registration, and GDP distribution.
Regulatory Expertise
Full-cycle drug registration, pricing, and inclusion in national lists (ALO, GOBMP, ED).
Market Access & Marketing
Formulary & protocol inclusion, hospital/ambulatory access, HCP education and research.
Medical Device Registration
Dedicated specialist: classification, dossier, state registration, and post-market surveillance.
GDP Distribution
Nationwide GDP-compliant logistics with quality and safety oversight.
AYAZ PHARM
EAEU Ready
Regulatory Desk
Frequently Asked Questions
What documents are required to register a medicinal product in Kazakhstan?
CTD/eCTD dossier (Module 1–5), GMP evidence, labeling/IFU in KZ/RU, pharmacovigilance system master file, local representation, and samples if requested by the authority.
How long does drug registration typically take?
On average 6–12 months depending on dossier readiness, class, and review cycles. Fast-track options may apply for priority products.
Can you support inclusion in the National Formulary and treatment protocols?
Yes. We prepare submissions, justify clinical value and cost-effectiveness, and communicate with relevant commissions for inclusion.
Do you handle pricing registration (caps) under GOBMP?
Yes. We register ceiling/wholesale/retail prices, monitor changes, and maintain compliance with MoH pricing regulations.
What is included in Market Access support (GOBMP/OSMS)?
Access mapping, budget-impact and pharmacoeconomic analyses, hospital/ambulatory listing strategy, tender monitoring, and HCP education.
Can you obtain advertising approvals for promotional materials?
Yes. We align claims with labeling, prepare the package for the authorized body, and track approvals for timely campaigns.
Do you register medical devices and who manages the process?
Yes. A dedicated specialist leads classification, dossier compilation, conformity assessment, state registration, and post-market surveillance.
Do you work under EAEU rules?
We follow current EAEU/KZ regulations for drugs and medical devices, including mutual recognition specifics where applicable.
How do you ensure GDP-compliant distribution?
We manage temperature-controlled logistics, quality and risk controls, documentation, and partner audits to maintain GDP compliance.
Do you monitor tenders (SK-Pharmacy, healthcare facilities)?
Yes. We provide ongoing tender intelligence, alerts, and submission support to maximize participation opportunities.
Do you provide pharmacovigilance services?
Yes. Signal detection, ICSRs, PSURs/PBRERs, local safety officer, and regulatory reporting per national requirements.
How are costs and timelines estimated?
After an initial assessment of your portfolio and target pathways, we issue a transparent proposal with milestones and fees.
How do you handle confidentiality and data protection?
We sign NDAs, restrict access on a need-to-know basis, and store data securely in line with internal policies and applicable laws.
How do we get started?
Send product/device basics (INN/class, indications, markets, dossier status). We’ll propose the optimal regulatory and market access route.
