of Pharmaceuticals
Registration
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
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
Do you want to register your product in CIS and EAEU?
Gaukhar Bilimbayeva,
General Director of Registrarius LLC, Head of Regulatory & PV, PharmD, MBA
General Director of Registrarius LLC, Head of Regulatory & PV, PharmD, MBA
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:
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:
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:
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:
To your request we provide you with our commercial proposal with a preliminary budget of your expenses for the ordered service
Partnership model with Registrarius LLC
Commercial offer
[01]
Partnership model with Registrarius LLC
Билимбаева
You enter into an Agreement with us and make payment for our services, in accordance with the Agreement terms
The contract and payment
[02]
Registrarius LLC starts project until its fully completion and delivery to the Client, according to the Agreement terms
Work Performance
[03]
1−12 months
Preparation of the dossier, standardsand samples
Up to 30 days
Dossier submission
From 270 till 450 calendar days
Registration process
Up to 10 days
Getting Health Authority final approval
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:
The way of medicines registration in CIS and EAEU consists of four main stages:
Registration process
1.1
Obtaining the dossier, samples and standards from the Client
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
- 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
1.2
Development of local documents
The timeline can be reduced if the Client provides the necessary materials for the development of local documents in advance
- Analytical Normative Document ArtWorks
- PIL
- Application
- Statement
- Translations in Kazakh/Russian languages
- Notarization of original documents
Stage #I
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!!! 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!!!
1—12 months
Up to 45 days
Preparation of the dossier, samples and standardsTimeline — from 1 month till 1 year
2.1
Conclusion Agreement with NCME
and getting a bill to pay for the state registration
2.2
Uploading the dossier on the Authority online portal
after receipt of payment to the bank account of NCME
Stage #II
Up to 21 days
Up to 7 days
2.3
Providing samples and standards to NCME
after receiving online confirmation from Authority
1 day
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
Duration — 1 month
NCME - National Center of Medicines Expertise of the Ministry of Health of CIS and EAEU
3.1
Initial examination dossier validation on:
- Entirety
- Completeness
- Correctness of documents
3.2
Specialized expertise
- Pharmacological
- Pharmaceutical
- Including translation of PIL and AW’s in the Kazakh language
Stage #III
30 days
Clock stop — 60 days
Clock stop — 60 days
Up to 90 days
Clock stop — 60 days
Clock stop — 60 days
3.3
Laboratory tests
- Samples testing
- identification of reproducibilityof the methods of analysis
Up to 70 days
Clock stop — 90 days
Clock stop — 90 days
3.4
Formation of Conclusion on safety, efficiency and quality
Up to 20 days
Clock stop — 30 days
Clock stop — 30 days
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
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
Stage #IV
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
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
Frequent risks in registration
and ways to overcome them
and ways to overcome them
Non-compliance of analytical methods with the State Pharmacopoeia of the Republic of Kazakhstan, absence of QOS, etc
Justifications supported by references to the EU and US Directives may be accepted by the Authority
Absence of samples and standards
Ability to conduct samples testing at the manufacturing site
Delaying of responses providing on Authority questions
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
Delaying of AW’s development and their corrections
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
— 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
Reliable partner
Our guarantee
— 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
Company experience
successful GMP inspections from KZ Authority
— more than 1000 successful regulatory approvals, including drugs, medical devices, food supplements, cosmetics, food, organization and maintenance of inspections and audits:
6
successful internal audits with a positive conclusion in GXP, GDP, GRP and GVP
4
quality control inspection
6
compliance audits
3
Behind our shoulders
Имя Фамилия
Make great presentations, longreads, and landing pages, as well as photo stories, blogs, lookbooks, and all other kinds of content oriented projects
Имя Фамилия
Make great presentations, longreads, and landing pages, as well as photo stories, blogs, lookbooks, and all other kinds of content oriented projects
Имя Фамилия
Make great presentations, longreads, and landing pages, as well as photo stories, blogs, lookbooks, and all other kinds of content oriented projects
Имя Фамилия
Make great presentations, longreads, and landing pages, as well as photo stories, blogs, lookbooks, and all other kinds of content oriented projects
Имя Фамилия
Make great presentations, longreads, and landing pages, as well as photo stories, blogs, lookbooks, and all other kinds of content oriented projects
Feedback of our work
Feedback of our work
Registrarius office in Uzbekistan
Registrarius office in Kazakhstan
Republic of Kazakhstan, Almaty 050000, Baiterek
Miras microdistrict, Tan Nury residential complex, 128, apartment 19
Sales department: +7 (700) 178-67-67
Miras microdistrict, Tan Nury residential complex, 128, apartment 19
Sales department: +7 (700) 178-67-67
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Outsourcing with REGISTRARIUS is fast and easy:
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The guarantee in keeping dead-lines
Negotiation of planning. Conclusion of Agreement
Work handover.
The start of work
The start of work
Monthly reports. On-line tracking of the products statuses. Participation in meetings
The cost saving
More time on business
Less taxes
Free FTE
Qualified managers
Do business, and we take over regulatory affairs and pharmacovigilance!
Outsourcing
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