Certification of cosmetics, hygiene products

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

Do you need to declare your cosmetics, hygiene products in the territory of CIS and EAEU?

Then you applied to a company that can really provide you highly qualified support, throughout the process of registering your product in CIS and EAEU, from the beginning to the end.

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

Partnership model with Registrarius LLC

III

Work Performance

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

II

The contract and payment

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

I

Commercial offer

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

Declaring process

In order for you to have an idea on what you will need for your product declaring 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 declaring ща perfume-cosmetic or hygiene means of an oral cavity products 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

The dossier and samples submission

Duration — from 1 month till 1 year

1.2

Development of local documents

  • Translation of the dossier into the Russian/Kazakh languages
  • Notarizing of the documents
  • Development of the local ArtWorks
  • Development of local instruction for use

The timeline could be decreased, if the Client provides necessary materials in advance

Up to 20 days

1.1

Receiving the dossier
and samples from the Client

  • Dossier according to requirements
    of CIS and EAEU
  • Samples for sanitary- hygienic tests (150 g)
  • Product ArtWorks in KZ/RU languages
  • Draft instructions for use
  • Certificates HACCP, ISO 13485, GMP
  • The copy of Supply Contract
  • The copy of invoice
  • The copy of state registration certificate

The timeline depends on the speed of providing full  package of documents and samples by the Client, including the time for samples custom clearance

1—12 months

Stage II

Submission of the dossier and materials on declaring

Duration — up to 3 days

2.2

Conclusion of the Agreement with Authority and getting the invoice for the state declaring

1 day

2.1

Submission of the dossier and samples to the Authority

1—3 days

Stage III

Declaring process

Duration — up to 14 calendar days / 2 weeks

3.2

Examination of the dossier

3.3

Assigning a registration number

inclusion in the unified register of certificates on state registration of the EAC (Eurasian Economic Commission)

3.1

Sanitary and
hygienic trial

  • composition analysis
  • analysis of physical-chemical indicators
  • determination of heavy metals, radionuclides, pesticides, microtoxins
  • microbiological tests
  • study of toxic effects on the body in acute trial on laboratory animals

Frequent risks and ways to overcome them

Discrepancy of perfume and cosmetics or oral hygiene products qualitative composition with the technical regulations of the

EAEURegistrarius LLC will provide a preliminary examination of the dossier in order to identify all discrepancies

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:

6

successful GMP inspections from KZ Authority

4

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

6

quality control inspection

3

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:

Kazakhstan
Kyrgyzstan
Uzbekistan
Azerbaijan
Armenia
Russia
Tajikistan
Turkmenistan
Mongolia
Belarus
Ukraine
Georgia
Moldova

Outsourcing

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:

I
Negotiation of planning.
Conclusion of Agreement.
II
Work handover.
The start of work.
III
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

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:

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

Sanofi

Jun 2012 — Mar 2015

Compliance officer in Kazakhstan, Central Asia and Caucasus countries

Novartis

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

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:

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

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:

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

Lawyer

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

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:

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

Aibyn Kurmanzhan

Product manager, Digital marketer.

Education:

2015 - 2019: Higher Medical College of Health Management in Almaty

2019 – studying a Bachelor’s degree: Moscow Financial and Industrial University “Synergy” Specialty Internet Marketer

Work experience:

Higher Medical College

2017 - 2019:

SMM Manager.

Registrarius LLC

2019 – at present:

Product manager, Digital marketer.

Bakitzhan Dauletay

Senior regulatory specialist

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:

Registrarius LLC

2019 - at present:

Senior regulatory specialist

Karakoz Abdrakhmanova

Senior regulatory and pharmacovigilance 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:

Registrarius LLC

2019 – at present:

Senior regulatory and pharmacovigilance specialist

Our experience

Feedback of our work

Registrarius LLC

Almaty 050000, Kazakhstan Baizakov str. 280
BC Almaty Towers, Coworking–center SmArt.Point-2, оf. 11