Registration of Pharmaceuticals

Do you want to register your product in CIS and EAEU?

Then you applied to a company that can really provide you with full and highly qualified support in the whole registration process of your product in CIS and EAEU, from initial beginning to end.

We are ready to answer all your questions for free and make a preliminary calculation of your expenses, including our services, via any convenient channel of communication.

Gaukhar Bilimbayeva,
General Director of Registrarius LLC, Head of Regulatory & PV, PharmD, MBA

Partnership model with Registrarius LLC


Work Performance

Registrarius LLC starts project until its fully completion and delivery to the Client, according to the Agreement terms


The contract and payment

You enter into an Agreement with us and make payment for our services, in accordance with the Agreement terms


Commercial offer

To your request we provide you with our commercial proposal with a preliminary budget of your expenses for the ordered service

Registration process

In order for you to have an idea on what you will need for your product registration in CIS and EAEU, we have prepared below a brief excursion on this question based on our more than 15 years’ experience in this field.

The way of medicines registration in CIS and EAEU consists of four main stages:

Each of the above described stages has its own processes, terms, nuances, risks, which we will help you successfully overcome with the maximum benefit for you!

Stage I

Preparation of the dossier, samples and standards

Timeline — from 1 month till 1 year


Development of local documents

  • Analytical Normative Document
  • ArtWorks
  • PIL
  • Application
  • Statement
  • Translations in Kazakh/
    Russian languages
  • Notarization of original

the timeline can be reduced if the Client provides the necessary materials for the development of local documents in advance

Up to 45 days


Obtaining the dossier, samples and standards from the Client

  • CTD dossier in pdf format
  • Samples and standards
    for triple lab. analysis
  • GMP certificates of production
    sites and CPP (apostilled)
  • Power of Attorney from
    manufacturer on License Holder
    on regulatory activity

Timeline depends from the speed of providing by the Client of full package of documents and materials, including the time for customs clearance of samples and standards

1—12 months

Stage II

The dossier and materials submission on registration

Duration — 1 month

NCME -  National Center of Medicines Expertise of the Ministry of Health of CIS and EAEU


Providing samples and standards to NCME

after receiving online confirmation from Authority

1 day


Uploading the dossier on the Authority online portal

after receipt of payment to the bank account of NCME

Up to 7 days


Conclusion Agreement with NCME

and getting a bill to pay for the state registration

Up to 21 days

Stage III

Registration process

Duration — 210 calendar days / 7 months *

* excluding clock-stops (time to eliminate Authority questions)

Including clock-stops at each stage a maximum of 450 calendar days / 15 months


Specialized expertise

  • Pharmacological
  • Pharmaceutical
  • Including translation of PIL
    and AW’s in the Kazakh language.

Up to 90 days

Clock stop — 60 days


Formation of Conclusion on safety, efficiency and quality

Up to 20 days

Clock stop — 30 days


Laboratory tests

  • Samples testing
  • identification of reproducibility
    of the methods of analysis

Up to 70 days

Clock stop — 90 days


Initial examination

dossier validation on:

  • Entirety
  • Completeness
  • Correctness of documents

30 days

Clock stop — 60 days

Stage IV

Getting of final approval from Authority

Duration — up to 10 days

Frequent risks in registration
and ways to overcome them

Absence of samples and standards

Delaying of responses providing on Authority questions

Delaying of AW’s development and their corrections

Non-compliance of analytical methods with the State Pharmacopoeia of the Republic of Kazakhstan, absence  of QOS, etc.

Sending a request for AW’s to the Client on 60 days prior to the submission of the dossier. In the case of a request for correction of text from an Authority, immediately sending a request to the Client and daily communications on the execution status, or the production and adjustment of packaging mock-ups by the designer of Registrarius LLC in constant communication with the plant.

Preparation of the maximum complete dossier to exclude requests from the Authority. Informing the Client about possible Authority questions at the stage of preparing the dossier.

Ability to conduct samples testing at the manufacturing site

Justifications supported by references to the EU and US Directives may be accepted by the Authority

A brand is not a logo. A brand is the promise you put out there and the experience you deliver

© Robert Kiyosaki

Dauren Bilimbayev, company founder,
Commercial/Marketing Director

If you can't explain it simply you don't understand it well enough

© Albert Einstein

Gaukhar Bilimbayeva, General Director of Registrarius LLP,
Head of Registration and Pharmacovigilance, PharmD, MBA

Obstacles are those frightful things you see when you take your eyes off your goal

© Henry Ford

Aida Badenova, Senior Regulatory and Pharmacovigilance manager,
MD (MA health management planning and policy)

Attract and keep smart people at work, you need to ensure that they are able to communicate with other smart people

© Bill Gates

Almas Ibraev, Head of Legal and Patent Protection, LLM Master of Laws

Reliable partner

Company experience

Our guarantee

— honor and reputation. It is in our interest to work in such a way that it would not be a shame for you to recommend us to your colleagues. To deceive, to bring is unacceptable for us.

— based on the professional experience of one of the founders and director of the company, Bilimbayeva Gaukhar, and the experience of each highly qualified team member in his industry, which in total amounts to 80 (eighty) years.

Behind our shoulders

— more than 1000 successful regulatory approvals, including drugs, medical devices, food supplements, cosmetics, food, organization and maintenance of inspections and audits:


successful GMP inspections from KZ Authority


successful internal audits with a positive conclusion in GXP, GDP, GRP and GVP


quality control inspection


compliance audits

We provide regulatory and

pharmacovigilance services
in 13 CIS the EAEU countries

and also we offer professional promotion services for your products in Kazakhstan, Kyrgyzstan, Uzbekistan, Azerbaijan, Armenia and Russia:



Do business, and we take over regulatory affairs and pharmacovigilance!

Less taxes
Free FTE
Qualified managers
More time on business
The cost saving
The guarantee in keeping dead-lines

Outsourcing with REGISTRARIUS is fast and easy:

Negotiation of planning.
Conclusion of Agreement.
Work handover.
The start of work.
Monthly reports.
On-line tracking of the products statuses.
Participation in meetings.

Our team is our pride

We have more than 50 international diplomas and certificates
confirming our high qualifications and standards:

Gaukhar Bilimbayeva

General Director of Registrarius LLC, Head of Regulatory & PV


1997 — 2002: Kazakh National Medical University, named of S.Asfendiyarov. Faculty, pharmacist of general practice.

2016 — 2018: MBA Swiss Business School, Zurich, Switzerland.

Work experience:

AstraZeneca UK in Kazakhstan

Mar 2016 — Jul 2018

Regulatory and PV manager, Medical Adviser, GxP Lead (GxP, GMP, GDP, GRP, GVP), Compliance Lead

Reckitt Benckizer

Oct 2015 — Feb 2016

Senior Regulatory and PV manager in Kazakhstan and Central Asia


Jun 2012 — Mar 2015

Compliance officer in Kazakhstan, Central Asia and Caucasus countries


Mar 2009 — May 2012

Head of Regulatory and PV Department and Compliance officer of Novartis GEM in Kazakhstan, Kyrgyzstan, Tajikistan  and Mongolia

Sandoz (Lek)

May 2007 — Apr 2009

Head of Regulatory and PV Department of Sandoz (Lek) in Kazakhstan, Kyrgyzstan, Tajikistan  and Mongolia

 Nur-May Pharmacy pharmaceutical factory (Kazakhstan)

Mar 2006 — May 2007

Head of Procurement

Nobel Kazakh-Turkish pharmaceutical factory

Aug 2005 — Mar 2006

Regulatory specialist

Aida Badenova

Regulatory and PV specialist of the Registrarius LLC


2014 — 2015: University of Leeds,  Nuffield Center for International Health and Development, United Kingdom. Master in Management, Planning and Policy in Public Health.

2003 — 2009: Medical University of Astana, Kazakhstan. Doctor hygienist-epidemiologist.

Work experience:

Registrarius LLC

jun 2018 by current time

Senior Regulatory and PV manager

Ministry of Health of the Republic of Kazakhstan

Nov 2017 — Dec 2018

Chief Expert of the Regional Development Department
Chief Expert of the Department of Implementation Coordination  compulsory social health insurance Department of Project Management

United Kingdom Department of Public Health, Health Promotion

Jan 2016 — Aug 2016

Consulate of the City of Leeds, Specialist (Internship)

Medical University of Astana, Kazakhstan

2009 — 2012

Department of Public Health, Senior Lecturer and Head of Department

Almas Ibrayev

Lawyer and Patent protection specialist in Registrarius LLC


2015 — 2016: Master (LLM) in the Bolashak program — The University of Leeds, Great Britain, Leeds;

1996 — 2000: Kazakh State Law Academy, Almaty,Kazakhstan

Work experience:

ТОО Registrarius

Jun 2018 by current time

Lawyer and Patent protection specialist

LLP "Central Asian Consultants“

Oct 2014 — May 2018

Deputy Director for Legal Affairs

National Mining Company of JSC "NC "Tau-Ken Samruk“

Oct 2009 — Oct 2014

Senior manager of Legal department

State Administration of Energy and Communal Services of Astana city Akimat of Astana city

May 2008 — Sep 2009

Senior specialist of legal department

Holding Company "Okan Holding“ Astana, Almaty city

Aug 2006 — Apr 2008


Agency of the Republic of Kazakhstan for the Regulation of Natural Monopolies in Astana

Sep 2005 — Jul 2006

Chief Specialist of the Legal Expertise Department of the Legal Department

Dauren Bilimbayev

Marketing & Sales Director in Registrarius LLC


2000 — 2004: Kazakh Economic University named after T. Ryskulov, Almaty, Kazakhstan, Faculty "Finance and credit", Specialty - taxes and taxation

2003 — 2005: East Kazakhstan State University named after S. Amanzholov, Kazakhstan, Faculty - Jurisprudence, Specialty - State Law

2016 — 2017: NIMA International Marketing school,  Netherlands

Work experience:

Center of Digital Dentistry Dr.Edil Boribay Almaty,Kazakhstan

2017 — 2018

Marketing & Sales director

Naiza EnergoRemKomplekt LLC, Almaty,Kazakhstan

2012 — 2017

Executive Director

Volvo Construction Equipment "Ak Machinery" LLP, Almaty, Kazakhstan

2011 — 2012

Regional Director

LLP Sapa Kurylys 2007, Almaty, Kazakhstan

2007 — 2011

Executive Director

Customs clearance center "Oskemen“

2001 — 2007

Chief Inspector of Customs Control Agency Department of East Kazakhstan Region

Kabylbekova Asmira

Senior specialist
of registration


2015-2019 Kazakh National Medical University, named of S.Asfendiyarov. Faculty, Bachelor degree

2019-2021 Kazakh National Medical University, named of S.Asfendiyarov. Faculty, Master degree

Work experience:

Registrarius LLC

2019 – at present:

Senior specialist
of registration, BE, PIL testing and CT

Bakitzhan Dauletay

Senior regulatory specialist


2015 - 2019: Kazakh National Medical University named after S.D.Asfendiyarov.

2019 - 2021: Master’s degree of technical sciences, Kazakh National Medical University named after S. Asfendiyarov

Work experience:

Registrarius LLC

2019 - at present:

Senior regulatory specialist

Karakoz Abdrakhmanova

Senior regulatory and pharmacovigilance specialist


2015 - 2019: Kazakh National Medical University named after S. Asfendiyarov

2019 – 2021: Master’s degree of medical sciences, «Kazakh National Medical University named after S. Asfendiyarov»

Work experience:

Registrarius LLC

2019 – at present:

Senior regulatory and pharmacovigilance specialist

Our experience

Feedback of our work

Registrarius LLC

Kazakhstan, Almaty 050000,
Microdistrict Samal-2, 58, block B, office 33

Sales department: +7 (771) 888 77 11, +7 (727) 313 12 07

Uzbekistan, Tashkent, 100000,
Massiv Kuruvchi - 2 - 96

+99 (871) 205 59 67