Dissolution profile test

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

Pharmacokinetic tests are expensive and time consuming. Therefore, in recent years, there has been an active discussion of the possibility in some cases of using the dissolution test, which is well known from pharmacopoeial analysis, or, more precisely, the comparative dissolution kinetics test (TSKR), to establish bioequivalence of generics. Of course, there is a problem of correlation between the results of experiments conducted in vitro and in vivo, since such a correlation is not always possible to identify. Moreover, despite the obvious differences in the in vitro release rate, significant differences in bioavailability may not be detected, and vice versa - the same indicators of the "dissolution" test do not always determine the bioequivalence of generics. Nevertheless, it is known that in the case of therapeutic inequivalence of drugs, there is often a difference in the rate of release of the active substance from the dosage form, which gives reason to use the "dissolution" test in some cases as an alternative to pharmacokinetic tests.

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For solid oral dosage forms (tablets, dragees, capsules, granules), the dissolution test is one of the most important quality criteria. In fact, its use in the analysis of a medicinal product is an attempt to introduce a test into ND, which, along with an assessment of pharmaceutical equivalence, would allow a preliminary assessment of bioequivalence.

Registrarius LLC has all the capabilities to carry out a comparative test of the dissolution profile of solid dosage forms in accordance with the modern requirements of the international expert organizations. The dissolution profile report is the part of registration dossier.

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Partnership model with Registrarius LLC


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


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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

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, office 33

Отдел продаж: +7 (700) 080 0550

СЕО: +7 (777) 426 43 26 , +7 (771) 888 77 11, +7 (727) 313 12 07

Uzbekistan, Tashkent,
Massiv Kuruvchi 2, office 96»

+99 (871) 205 59 67