Gaukhar Bilimbayeva, CEO of Registrarius Pharm Expert
OF MEDICINES IN
TURKMENISTAN

REGISTRATION OF MEDICINES IN TURKMENISTAN

Planning to launch a medicinal product on the market of Turkmenistan?
You’ve come to the right place. Registrarius Pharm Expert will guide your product through the entire regulatory pathway – from registration dossier preparation to obtaining the marketing authorization. We structure the process to minimize deficiencies, rework and delays.

With over 20 years of experience, we have completed more than 2,000 successful registrations of medicines, medical devices, food supplements, cosmetics, and food products in the CIS countries.

Free initial consultation and cost estimate – we will answer all your questions and calculate the project budget through any communication channel convenient for you
Gaukhar Bilimbayeva, CEO of Registrarius Pharm Expert LLP, PharmD, MBA
We provide
registration
and pharmacovigilance services in the CIS countries, the EAEU, and Mongolia
We provide registration and pharmacovigilance services in the CIS countries, the EAEU, and Mongolia[…]
Kazakhstan
Kazakhstan
Türkiye
Türkiye
Uzbekistan
Uzbekistan
Tajikistan
Tajikistan
Georgia
Georgia
Azerbaijan
Azerbaijan
Russia
Russia
Mongolia
Mongolia
Belarus
Belarus
Turkmenistan
Turkmenistan
Moldova
Moldova
Kyrgyzstan
Kyrgyzstan
Armenia
Armenia
Ukraine
Ukraine
Upon receipt of your request, we will prepare a personalized commercial proposal with a detailed calculation of the full budget for the registration of your product in Turkmenistan. No hidden fees – you see the final price before the contract is signed.
PARTNERSHIP MODEL WITH REGISTRARIUS PHARM EXPERT
COMMERCIAL PROPOSAL
[01]
Bilimbayev Dauren,
Founder of Registrarius Pharm Expert
We sign an official contract with clearly defined timelines, obligations of the parties, and payment procedure. Payment is made in accordance with the terms of the agreement – flexibly and conveniently for your accounting department.
CONTRACT AND PAYMENT
[02]
Registrarius Pharm Expert manages the project from kick-off to handover to the Client in full compliance with the contract terms. You receive regular progress reports on the registration, prompt feedback, and support at every stage of interaction with the Authority.
PROJECT EXECUTION
[03]
FROM 1 TO 12 MONTHS
Preparation of the registration dossier, reference standards and samples
UP TO 14 DAYS
Submission of the dossier and samples for registration
UP TO 6 MONTHS
Examination procedure and issuance of the registration certificate
Planning to launch a medicinal product on the pharmaceutical market of Turkmenistan? We have prepared for you a clear breakdown of all stages of state registration.

Our experience in the registration of medicines in the CIS countries is backed by proven procedures and realistic timelines. Only working solutions, no inflated promises.
STATE REGISTRATION PROCESS FOR MEDICINES
1.1
2.1
RECEIPT OF THE DOSSIER, REFERENCE STANDARDS AND SAMPLES FROM THE MANUFACTURER
EXAMINATION AND REGISTRATION PROCEDURE
At this sub-stage, the basis for the state registration of the product is formed: the registration dossier, reference standards and samples are collected

Timelines depend directly on how quickly the manufacturer provides the complete package of documents, reference standards and samples, and we, in turn, shorten them by giving the manufacturing site precise and clear requirements from the outset.
The most critical stage. Experts of the authority carry out a comprehensive review of the product dossier and samples The examination includes assessment of the dossier documents and laboratory verification, on samples of the product, of the reproducibility of the submitted quality control methods, while issues of safety, quality and efficacy are reviewed by the Pharmacological and Pharmacopoeial Committees of the Ministry of Health and Medical Industry. At each stage, the experts may issue deficiency letters, and the speed and quality of the responses determine the overall registration timeline. Our specialists promptly address all queries and deficiencies to minimize clock-stops and avoid delays in obtaining the Certificate of State Registration.
1.2
2.2
ADAPTATION OF DOCUMENTS TO THE REQUIREMENTS OF TURKMENISTAN
ISSUANCE OF THE CERTIFICATE OF STATE REGISTRATION
In parallel, our team prepares a package of documents adapted to the requirements of the State Center for Registration of Medicines:
The final stage – inclusion of the product in the State Register of Medicines and Medical Products and issuance of the Certificate of State Registration valid for 5 years, which confirms the safety, efficacy and quality of the product and grants the right to import and market it in the territory of Turkmenistan.
  • Translation of the dossier documents into Russian, and of the instructions for use into Turkmen, Russian and/or English
  • Development of the instructions for use
  • Preparation of the application and submission of the dossier for state registration
Stage #I
Each of the above stages has its own processes, timelines, nuances and risks, which we will help you successfully overcome with maximum benefit for you!!! Each of the above stages has its own processes, timelines, nuances and risks, which we will help you successfully overcome with maximum benefit for you!!! Each of the above stages has its own processes, timelines, nuances and risks, which we will help you successfully overcome with maximum benefit for you!!!
1–12 months
up to 180 calendar days
up to 30 days
within the 180 calendar days
Preparation of the dossier, reference standards and samples
Duration – from 1 to 12 months
Stage #II
Submission of the dossier and samples, examination and registration
Duration – up to 14 days for submission, up to 180 calendar days for examination and registration / 6 months
The foundation of the registration procedure. Many of the deficiencies that cause the examination to drag on for months originate right here, before submission. We know which nuances are critical for the experts of the Authority, and we build the dossier so that as few questions as possible arise during the examination.
Once the dossier is fully assembled, the documents, reference standards and samples are officially submitted to the State Center for Registration of Medicines of the Ministry of Health and Medical Industry of Turkmenistan.
You don't need to figure out the national specifics – that is our area of responsibility. The timeline can be shortened if the manufacturer provides source materials in advance.
Common registration risks
and ways to overcome them
Non-reproducibility of quality control methods during laboratory examination
Preliminary verification of quality control methods and timely delivery of samples and working standards in quantities sufficient for testing.
Late provision of samples or responses to expert queries by the manufacturer
Informing the manufacturer about possible queries at the dossier preparation stage and monitoring the timelines for providing samples and responses.
Integrity and reputation are the foundation of our business.
We work so that, after the project is completed, you will want to recommend us to colleagues and partners. Every marketing authorization, every completed stage, is a contribution to the Company name we build painstakingly and meticulously, year after year.
The cost of a mistake is months of lost time and a derailed product launch. We understand this and therefore work with full responsibility for every stage and every document.
Deception, failure to deliver, or shifting responsibility are absolutely unacceptable to us. We take on a project only when we are confident that we will see it through to a successful outcome in the shortest possible timeframe.
A RELIABLE PARTNER IN MEDICINES REGISTRATION
Our guarantee
Registrarius Pharm Expert is built upon the professional expertise of one of its founders and the CEO of the company – Gaukhar Bilimbayeva,
120 years of combined team experience, GMP inspections and audits
Over these years, we have progressed from registering straightforward generics to complex cases involving biological products, medical devices and non-standard manufacturing sites. This experience is your insurance against delays, refusals and rework
Company experience
successful GMP inspections by the Authorities of the CIS
more than 2,000 successful regulatory approvals, including medicines, medical devices, food supplements, cosmetics, and food products; we have organized and supported inspections and audits:
More than 30
successful internal audits with a positive GXP, GRP and GVP conclusion
More than 50
successful quality control inspections
More than 10
Our track record
Outsourcing
Focus on your business, while we take care of registration and pharmacovigilance!
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Proud of our team
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Gaukhar Bilimbayeva
Gulzhan Akhmetova
Anna Polivoda
Dauren Bilimbayev
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Maxim Sevostyanov
Bulegenova Zhadyra
Jenis Kamila
Asel Seidakhmetova
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We have over 50 international diplomas and certificates confirming our high qualifications and standards:
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
Training certificate
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dr.theiss naturwaren
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gsk
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Client testimonials
Client testimonials

Frequently asked questions about the registration of medicines in Turkmenistan

How long does it take to register a medicinal product in Turkmenistan?

Preparation of the dossier, reference standards and samples takes from 1 to 12 months. This is followed by up to 14 days for submission and up to 180 calendar days for examination and registration.

What document is issued upon registration of a medicine in Turkmenistan?

The product is included in the State Register of Medicines and Medical Products, and a Certificate of State Registration valid for 5 years is issued, granting the right to import and market the product in Turkmenistan.

Where are the documents for the registration of a medicine in Turkmenistan submitted?

The documents, reference standards and samples are submitted to the State Center for Registration of Medicines of the Ministry of Health and Medical Industry of Turkmenistan. Issues of safety, quality and efficacy are reviewed by the Pharmacological and Pharmacopoeial Committees.

In what language are the documents for registration in Turkmenistan prepared?

The dossier documents are translated into Russian, and the instructions for use into Turkmen, Russian and/or English. The instructions for use are also developed, and the application for state registration is prepared.

What is checked during the laboratory examination in Turkmenistan?

Laboratory verification of the reproducibility of the submitted quality control methods is carried out on samples of the product. To reduce the risk of non-reproducibility, the methods are checked in advance, and samples and working standards are supplied in sufficient quantities.

REGISTRARIUS PHARM EXPERT office in Uzbekistan
REGISTRARIUS PHARM EXPERT office in Kazakhstan
Tashkent, 100000,
2 Quruvchi Massiv
Sales hotline: +7 (700) 178-67-67
Mail: info@registrarius.org
Republic of Kazakhstan, Almaty 050000
Miras microdistrict, Tan Nury residential complex, 128, apartment 19
Sales hotline: +7 (700) 178-67-67
Mail: info@registrarius.org
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Outsourcing with Registrarius Pharm Expert is simple and fast:
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Guaranteed deadlines
Planning negotiations.
Contract signing
Handover. Project launch
Monthly reports.
Online tracking
of product statuses.
Participation in reporting meetings
Cost savings
More time for business
Lower taxes
Freeing up a staff position
Qualified managers
Focus on your business, while we take care of registration and pharmacovigilance!
Outsourcing
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