Pharmacovigilance
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 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 Authorized Person for Pharmacovigilance in CIS and EAEU
Do you need an Authorized Person for Pharmacovigilance in CIS and EAEU?
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]
Gaukhar Bilimbayeva,
General Director of Registrarius LLC
General Director of Registrarius LLC
Bilimbayeva
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
Appointment of the Authorized Person (APP) for Pharmacovigilance in CIS and EAEU
Up to 30 days
Fulfillment by APP of Pharmacovigilance requirements of the CIS and EAEU
from 270 to 450 calendar days
Reporting to the Client on the status of pharmacovigilance activities
In order for you to have an idea on what you will need to carry out pharmacovigilance in CIS and EAEU, we have prepared below a brief excursion on this question based on our more than 15 years of experience in this field
Pharmacovigilance in CIS and EAEU of Medicines, Medical Devices consists of three main stages:
Pharmacovigilance in CIS and EAEU of Medicines, Medical Devices consists of three main stages:
Pharmacovigilance Process
1.1
Getting the letter from the Marketing Authorization Holder on the appointment of an APP
The time depends on the speed of providing the letter by Client
1.2
Submission of the letter to Authority
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!!! 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!!!
Up to 1 month
1 day
Appointment of the Authorized Person for Pharmacovigilance (APP) in CIS and EAEU
Duration — up to 1 month
Duration — up to 1 month
2.1
General Pharmacovigilance support performed by APP
- Weekly search local literature (specialized newspapers, magazines, websites) and Health Authorities website Screening; Monthly report of local literature search and web site monitoring
- Work with CIOMs-reports from MAH (Marketing Authorization Holders), processing and analysis, filling Line-listings, preparation the monthly summary reports, monthly submission them to the HA
- Activities related to the PSUR, DSUR and etc (includes preparation of Cover Letter +ordering translation(cost of translation is separate)+submission of final PSUR to Authority): providing PSUR submission Schedule to the CA, monitoring of the timeliness and the provision of PSUR to HA in accordance with local laws
- Communication to Client of new national laws and regulation related with the Pharmacovigilance activity in the Territory.
- Registration as local APP and coordination with authority, includes 24/7 availability
- Receiving and reporting of ICSR’s
2.2
Additional support on Pharmacovigilance
- Development of PSUR, DSUR, RMP
- Other additional activities, preparation of extra reports for the client, additional TC's, providing of PV training, support during Audit if necessary and etc
- Business trips for investigation of ICSR’s
Stage #II
Up to 21 days
Up to 7 days
Fulfillment of Pharmacovigilance requirements of CIS and EAEU by APP
Stage #III
Reporting of pharmacovigilance activities status to the Client. Types and timeline of reports are performed in accordance with Contract terms
Risks in violation of Pharmacovigilance requirements of the CIS and EAEU
Non-compliance of analytical methods with the State Pharmacopoeia of the Republic of Kazakhstan, lack of QOS, etc.
Justifications supported by references to EU and US directives may be accepted by the Authorized Body
Lack of samples and standards
The possibility of conducting an analytical examination at the factory
Long response times to NCELS comments from the factory: 30 days or more
Preparation of a maximum complete dossier, to exclude requests from the Authorized Body. Informing the plant about possible requests at the stage of dossier preparation
Duration of the packaging design process and its adjustment From 30 days or more
Request for packaging layouts to be generated 60 days before the submission of the dossier. In the event of a request for text adjustments from the authorized body, immediate submission of the request to the factory and daily communication on the status of execution, or the production and adjustment of packaging layouts by the designer of Registrarius LLP in constant communication with the factory
— 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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