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.
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.
Registrarius LLC starts project until its fully completion and delivery to the Client, according to the Agreement terms
You enter into an Agreement with us and make payment for our services, in accordance with the Agreement terms
To your request we provide you with our commercial proposal with a preliminary budget of your expenses for the ordered service
— 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
successful internal audits with a positive conclusion in GXP, GDP, GRP and GVP
quality control inspection
We provide regulatory and
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!
We have more than 50 international diplomas
confirming our high qualifications and standards:
1997 — 2002: Kazakh National Medical University, named of S.Asfendiyarov.
Faculty, pharmacist of general practice.
2016 — 2018: MBA Swiss Business School, Zurich, Switzerland.
Mar 2016 — Jul 2018
Regulatory and PV manager, Medical Adviser, GxP Lead (GxP, GMP,
GDP, GRP, GVP), Compliance Lead
Oct 2015 — Feb 2016
Senior Regulatory and PV manager in Kazakhstan and Central
Jun 2012 — Mar 2015
Compliance officer in Kazakhstan, Central Asia and Caucasus
Mar 2009 — May 2012
Head of Regulatory and PV Department and Compliance officer of
Novartis GEM in Kazakhstan, Kyrgyzstan, Tajikistan and Mongolia
May 2007 — Apr 2009
Head of Regulatory and PV Department of Sandoz (Lek) in
Kazakhstan, Kyrgyzstan, Tajikistan and Mongolia
Mar 2006 — May 2007
Head of Procurement
Aug 2005 — Mar 2006
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.
jun 2018 by current time
Senior Regulatory and PV manager
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
Jan 2016 — Aug 2016
Consulate of the City of Leeds, Specialist (Internship)
2009 — 2012
Department of Public Health, Senior Lecturer and Head of
2015 — 2016: Master (LLM) in the Bolashak program — The University of Leeds,
Great Britain, Leeds;
1996 — 2000: Kazakh State Law Academy, Almaty,Kazakhstan
Jun 2018 by current time
Lawyer and Patent protection specialist
Oct 2014 — May 2018
Deputy Director for Legal Affairs
Oct 2009 — Oct 2014
Senior manager of Legal department
May 2008 — Sep 2009
Senior specialist of legal department
Aug 2006 — Apr 2008
Sep 2005 — Jul 2006
Chief Specialist of the Legal Expertise Department of the Legal
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
2017 — 2018
Marketing & Sales director
2012 — 2017
2011 — 2012
2007 — 2011
2001 — 2007
Chief Inspector of Customs Control Agency Department of East
2015 - 2019: Higher Medical College of Health Management in Almaty
2019 – studying a Bachelor’s degree: Moscow Financial and Industrial University
Specialty Internet Marketer
2017 - 2019:
2019 – at present:
Product manager, Digital marketer.
2015 - 2019: Kazakh National Medical University named after
2019 - 2021: Master’s degree of technical sciences, Kazakh National Medical
University named after S. Asfendiyarov
2019 - at present:
Senior regulatory 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»
2019 – at present:
Senior regulatory and pharmacovigilance specialist
Medical Affairs Lead Primary Care
CIS Regulatory manager
Senior regulatory manager
Regulatory Affairs manager