Do you want to register your Medical Device or Medical equipment 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.
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
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.
Getting Health Authority final approval
Up to 10 days
Registration process
Depending from safety class of medical device from 90 to 400 calendar days
Dossier submission
Up to 30 days
Preparation of the dossier, standardsand samples
1—12 months
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!
the timeline can be reduced if the Client provides the necessary
materials for the development of local documents in advance
Up
to 30 days
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
NCME - National Center of Medicines Expertise of the Ministry of Health of CIS and EAEU
after receiving online confirmation from Authority
1 day
after receipt of payment to the bank account of NCME
Up to 7 days
and getting a bill to pay for the state registration
Up to 21 days
* excluding clock-stops (time to eliminate Authority questions)
Including clock-stops at each stage a maximum:
Class 1 and 2A -
330 calendar days / 11 months
Class 2B and 3 - 400 calendar days
/ 13 months
Class 1 and 2A — up to 40 days
Class 2b and 3 — up to 70 days
Clock stop — 60 days
For countries in the ICH region, do not provide samples for laboratory testing.
Class 1 and 2A — up to 30 days
Class 2b and 3 — up to 60 days
Clock stop — 90 days
Class 1 and 2A — 10 days
Class 2B and 3 — 20 days
Clock stop — 60 days
Up to 10 days
Clock stop — 30 days
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!
We have more than 50 international diplomas and certificates
confirming our high qualifications and standards:
Background:
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:
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 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
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
Regulatory specialist
Background:
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:
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 Department
Background:
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:
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
Lawyer
Sep 2005 — Jul 2006
Chief Specialist of the Legal Expertise Department
of the Legal Department
Background:
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:
2017 — 2018
Marketing & Sales director
2012 — 2017
Executive Director
2011 — 2012
Regional Director
2007 — 2011
Executive Director
2001 — 2007
Chief Inspector of Customs Control Agency Department
of East Kazakhstan Region
Education:
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:
2019 - at present:
Senior regulatory specialist
Education:
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:
2019 – at present:
Senior regulatory and pharmacovigilance
specialist
Medical Affairs Lead Primary Care
CIS Regulatory manager
Regulatory manager
Senior regulatory manager
Regulatory Affairs manager
