Legal market entry into Kazakhstan (EAEU) without risks.

We handle all regulatory affairs, translations and communication with state bodies. Registration of medical devices, supplements and cosmetics from 4 months with a contractual result guarantee.

✓ Result guaranteed by contract ✓ Pay per milestone ✓ NDA before any documents

TRUSTED BY Medical Manufacturers of Germany | Biotech Startups from South Korea | Dental Suppliers in China | Global Pharma Enterprises | TRUSTED BY Medical Manufacturers of Germany | Biotech Startups from South Korea | Dental Suppliers in China | Global Pharma Enterprises

80% of agencies
miss their deadlines.

That's why we introduced a split-payment model and a three-tier internal audit. We share the financial risk with you.

Zhangir Smagulov

CEO Axis Reg

Zhangir Smagulov, CEO Axis Reg

Why do you lose 6+ months
before your first sale?

01.

Incorrectly assembled dossier

Ministry of Health rejections and frozen investments over a single comma or incorrect translation.

02.

Hidden Fees

Marked-up state duties and surprise surcharges that appear mid-registration.

03.

"Black Box"

Zero communication from your contractor. Hundreds of thousands lost on idle inventory.

We solve these problems systematically.

See our competencies

Core Competencies

Registration Dossier Preparation

Professional preparation and audit of documents in strict accordance with state requirements.

Expertise Support

Direct interaction with expert organizations and rapid resolution of any inquiries during the registration process.

Technical File

Medical translation, adaptation of instructions, and risk management files strictly according to nomenclature.

Cosmetics & Disinfectants

Full cycle registration of cosmetic products and disinfectants in health authorities.

0+

Successful registrations

0%

Rejections due to our fault

0

Months on average to market entry

Typical Agency

  • 100% upfront payment before work begins
  • Hidden markups on state duties
  • No guarantees if the Ministry of Health rejects

Axis Reg

  • Milestone payments (40/30/30)
  • You pay state duties directly — no markups
  • Free re-submission if rejected
  • 24/7 client dashboard with transparent status

Architecture of the process

Stage 1

Dossier Adaptation

Dossier compilation, medical translation, and technical file formation.

Stage 2

Submission & Expertise

Official submission of the dossier, passing primary and specialized expertise.

Stage 3

Laboratory Testing

Analytical stage and obtaining a conclusion on the safety and quality of the device.

Final

RC / SRC Issuance

Official receipt of the Registration Certificate (RC) or State Registration Certificate (SRC).

Solving the unsolvable

A detailed breakdown of how we overcome bureaucratic dead-ends for our clients.

Supplements

Vitamin Complex (EU)

Successful registration of complex formula. SGR obtained in 4 months.

Medical Device

Medical Masks

Fast-track registration for a large distributor. RU obtained in 6 months.

Medical Device

Sterile Gloves

Technical file adaptation and successful laboratory testing.

Medical Device

Bandages & Dressings

Registration of a product line for a local manufacturer.

Med Device (Class 3)

Dental Implants

Complex registration of high-risk devices with clinical justification.

Med Technology

ECG Monitors

Turnkey registration for equipment from South Korea.

Cosmetics

Dermatological Cosmetics

Obtaining SGR for a new line of therapeutic cosmetic products.

Disinfection

Antiseptic Solutions

Registration of disinfectants for medical institutions.

Intellectual capital — documents and structured knowledge, abstract imagery without people

Intellectual
Capital

Your project will be handled by specialists with 10+ years of domain experience. We do not hire interns for million-dollar contracts.

  • Former auditors of state bodies
  • Certified medical translators
  • International regulatory consultants

Unprecedented Data Protection

We understand the value of your dossier. A strict NDA is signed before the first document is transferred. All data is stored on secured servers with bank-level encryption.

Transparent pricing

Under EU/EAEU rules, devices are grouped into risk classes: higher classes mean a fuller dossier and stricter review. We support registration across all classes, including Class IIb and Class III — implantable and other high-risk devices. Scope and fee estimates are agreed before work begins — no hidden charges.

Basic Consulting

For those with an existing dossier (incl. Class 1, 2a)

Individual calculation

Premium

Turnkey Service

Incl. complex translations and Classes 2b, 3

Individual calculation

Free Guide 2026

10 Critical Mistakes
When Submitting a Dossier to the State Body

Discover the non-obvious details that cause the Ministry of Health to reject 40% of applications on the first try. Save yourself 3 to 6 months.

No spam. Just the essentials.

Calculate the cost
in 1 minute

Step 1 of 3 33%

Step 1: What are we registering?

Step 2: Country of manufacture?

Step 3: Do you have an existing dossier?

Excellent!

Leave your contacts — we’ll email a personal PDF estimate and follow up on WhatsApp within 15 minutes.

Estimate arrives instantly. Manager follows up on WhatsApp.

Frequently Asked Questions

We reduce the risk to <1% through deep internal QA audits. If a rejection occurs due to our fault, we provide a free re-submission — this is strictly stipulated in the contract.

Yes. Our staff includes certified medical translators. If you have documentation only in English, we will prepare a professional translation into Russian and Kazakh in accordance with the regulator's requirements.

No. The entire process is handled completely remotely. We act on your behalf on the basis of a notarized power of attorney, saving you from flights and bureaucracy.

Ready to Begin?

Submit a request for a free audit of your dossier. We will contact you within one hour.

Schedule an Audit
Get an estimate