QUALIFIED PERSON
FOR PHARMACOVIGILANCE (MAH QPPV)
FOR PHARMACOVIGILANCE
(MAH QPPV)
(MAH QPPV)
Does the regulatory authority or the legislation of your country require you to appoint an MAH QPPV?
You’ve come to the right place. Registrarius Pharm Expert assumes the functions of the Qualified Person for Pharmacovigilance of the marketing authorization holder (MAH QPPV) and supports your pharmacovigilance system throughout the entire life cycle of the medicinal product. No regulatory risks, overdue obligations or last-minute rushes before an inspection.
Over 20 years in pharmaceutical regulation. International
and local pharmaceutical companies trust us with pharmacovigilance support — for products across various therapeutic areas.
Free initial consultation and preliminary assessment of the scope of services – we will answer your questions, analyze your current pharmacovigilance system and propose the optimal solution tailored to your company's specifics.
You’ve come to the right place. Registrarius Pharm Expert assumes the functions of the Qualified Person for Pharmacovigilance of the marketing authorization holder (MAH QPPV) and supports your pharmacovigilance system throughout the entire life cycle of the medicinal product. No regulatory risks, overdue obligations or last-minute rushes before an inspection.
Over 20 years in pharmaceutical regulation. International
and local pharmaceutical companies trust us with pharmacovigilance support — for products across various therapeutic areas.
Free initial consultation and preliminary assessment of the scope of services – we will answer your questions, analyze your current pharmacovigilance system and propose the optimal solution tailored to your company's specifics.
Gaukhar Bilimbayeva,
CEO of Registrarius Pharm Expert LLP, PharmD, MBA
CEO of Registrarius Pharm Expert LLP, PharmD, MBA
Upon receipt of your request, we analyze your company's needs and prepare an individual commercial proposal based on the scope of pharmacovigilance services in the MAH's country. You receive a transparent cost calculation in advance, with no hidden fees
or additional costs.
or additional costs.
PARTNERSHIP MODEL WITH REGISTRARIUS PHARM EXPERT
Commercial proposal
[01]
Bilimbayev Dauren,
Founder of Registrarius Pharm Expert
Founder of Registrarius Pharm Expert
We sign an official contract with clearly defined obligations of the parties, the list of services provided and the interaction procedure. We agree on the information exchange channels, responsible persons
and the procedure for performing the MAH QPPV functions.
and the procedure for performing the MAH QPPV functions.
CONTRACT AND START OF COOPERATION
[02]
Once cooperation begins, Registrarius Pharm Expert specialists perform the MAH QPPV functions in accordance with the legislative requirements of the MAH's country.
We organize support for the pharmacovigilance system and ensure monitoring of compliance with regulatory requirements, timely processing of safety information on medicinal products, interaction with the Authorities and ongoing expert support throughout the term of the contract.
We organize support for the pharmacovigilance system and ensure monitoring of compliance with regulatory requirements, timely processing of safety information on medicinal products, interaction with the Authorities and ongoing expert support throughout the term of the contract.
PHARMACOVIGILANCE SUPPORT
[03]
STAGE #I
Signing of the contract, appointment of the MAH QPPV and setting up the pharmacovigilance system
STAGE #II
Preparation and implementation of the necessary pharmacovigilance documentation
SERVICE DELIVERY
Performance of the MAH QPPV functions:
support of the
pharmacovigilance system, interaction
with regulatory authorities and
ensuring compliance with the requirements of the MAH's country.
support of the
pharmacovigilance system, interaction
with regulatory authorities and
ensuring compliance with the requirements of the MAH's country.
Need to appoint a Qualified Person for Pharmacovigilance of the marketing authorization holder to meet the legislative requirements of the MAH's country?
We perform the MAH QPPV functions by organizing an effective pharmacovigilance system in accordance with the legislative requirements of the MAH's country. From developing documentation and organizing processes to monitoring the safety of medicinal products and interacting with the Authorities – all tasks are under the control of our specialists.
We perform the MAH QPPV functions by organizing an effective pharmacovigilance system in accordance with the legislative requirements of the MAH's country. From developing documentation and organizing processes to monitoring the safety of medicinal products and interacting with the Authorities – all tasks are under the control of our specialists.
QUALIFIED PERSON FOR PHARMACOVIGILANCE OF THE MARKETING AUTHORIZATION HOLDER (MAH QPPV) SERVICE
1.1
RECEIPT OF THE DOSSIER, REFERENCE STANDARDS AND SAMPLES FROM THE MANUFACTURER
At this sub-stage, the basis for the state registration of the medicinal product in the EAEU is formed: the necessary materials are collected, the registration dossier is prepared, and reference standards
and samples are requested in accordance with the requirements of
EEC Council Decision No. 78.
Timelines depend directly on how quickly the manufacturer provides the complete package of documents and samples.
and samples are requested in accordance with the requirements of
EEC Council Decision No. 78.
Timelines depend directly on how quickly the manufacturer provides the complete package of documents and samples.
1.2
DEVELOPMENT OF LOCAL DOCUMENTS
In parallel, our team prepares a package of documents adapted to the requirements of the Eurasian Economic Union:
- Translation of documentation into the state languages of the Member States of the Union
- Adaptation of packaging mock-ups to EAEU labeling requirements
- Development and preparation of local documents according to the requirements of the country of application
- Preparation of the complete set of documents and the application for state registration
Stage #I
Each of the above stages has its own processes, timelines, nuances and risks, which we will help you successfully overcome with maximum benefit for you!!! Each of the above stages has its own processes, timelines, nuances and risks, which we will help you successfully overcome with maximum benefit for you!!! Each of the above stages has its own processes, timelines, nuances and risks, which we will help you successfully overcome with maximum benefit for you!!!
1-12 months
up to 45 days
Preparation of the dossier and local documents
Duration – from 1 to 12 months
Duration – from 1 to 12 months
Stage #II
Stage #III
Electronic version – 10 working days. Paper version – up to 3 months.
The final stage — issuance of the EAEU marketing authorization confirming the safety of the medicinal product and the right to market it. The data are entered in the Unified Register of Registered Medicines of the Union, and the marketing authorization holder is able to expand its presence to the markets of other Member States of the Union under the recognition procedure.
The final stage — issuance of the EAEU marketing authorization confirming the safety of the medicinal product and the right to market it. The data are entered in the Unified Register of Registered Medicines of the Union, and the marketing authorization holder is able to expand its presence to the markets of other Member States of the Union under the recognition procedure.
ISSUANCE OF THE EAEU MARKETING AUTHORIZATION
Examination and registration procedure
Duration – 140 working days / 7 months
**excluding clock-stops (time for addressing deficiency letters). Including clock-stops at each stage — maximum of 410 working days
Duration – 140 working days / 7 months
**excluding clock-stops (time for addressing deficiency letters). Including clock-stops at each stage — maximum of 410 working days
Obtaining approval from the Authority Duration — up to 10 working days
The foundation of the procedure. TR CU 007/2011 provides for three forms of conformity assessment: state registration followed by declaration, declaration, and mandatory certification. The entire further path of the products depends on how correctly the form is determined and the dossier is compiled at this stage.
Once the dossier is fully assembled, the documents are officially submitted to the Authority, and the examination of the dossier and samples under the procedure established by EAEU rules begins.
The most critical stage. Experts of the Authority carry out a comprehensive review of the product dossier and samples in accordance with EAEU rules, while our specialists promptly address all queries and deficiencies to minimize clock-stops and avoid delays in obtaining the marketing authorization.
The timeline can be shortened if the manufacturer provides source materials in advance.
COMMON PHARMACOVIGILANCE RISKS
AND WAYS TO PREVENT THEM
AND WAYS TO PREVENT THEM
Absence of a Qualified Person for Pharmacovigilance or non-compliance with the legislative requirements of the MAH's country
Appointment of a qualified MAH QPPV and performance of all functions in accordance with the pharmacovigilance legislation of the MAH's country.
Outdated or missing pharmacovigilance documentation
Development, updating and maintenance of all necessary documentation, including the PSMF, SOPs, PSURs, RMPs and other pharmacovigilance system documents.
Lack of readiness for a pharmacovigilance inspection
Assessment of system readiness, identification of potential non-conformities and support of the company at all stages of the inspection.
Breach of the regulatory obligations of the marketing authorization holder
Monitoring compliance with the legislative requirements of the MAH's country, interaction with the Authority and support of all obligations of the marketing authorization holder
in the field of pharmacovigilance.
in the field of pharmacovigilance.
Pharmacovigilance is not a one-off service, but an ongoing responsibility for the safety of medicinal products and compliance with the legislative requirements of the MAH's country.
We organize our work so that the marketing authorization holder is confident in the reliability of its pharmacovigilance system. Every adverse reaction report, every document prepared and every regulatory deadline met –
is the responsibility of our team.
Our goal is not merely to meet the formal legislative requirements, but to build a pharmacovigilance system that runs smoothly and keeps the product's safety profile under constant control.
We organize our work so that the marketing authorization holder is confident in the reliability of its pharmacovigilance system. Every adverse reaction report, every document prepared and every regulatory deadline met –
is the responsibility of our team.
Our goal is not merely to meet the formal legislative requirements, but to build a pharmacovigilance system that runs smoothly and keeps the product's safety profile under constant control.
A RELIABLE PARTNER
IN PHARMACOVIGILANCE
IN PHARMACOVIGILANCE
Our guarantee
Registrarius Pharm Expert is built upon the professional expertise of one of its founders and the CEO of the company – Gaukhar Bilimbayeva,
120 years of combined team experience, GMP inspections and audits
Over these years, we have progressed from registering straightforward generics to complex cases involving biological products, medical devices and non-standard manufacturing sites. This experience is your insurance against delays, refusals and rework
120 years of combined team experience, GMP inspections and audits
Over these years, we have progressed from registering straightforward generics to complex cases involving biological products, medical devices and non-standard manufacturing sites. This experience is your insurance against delays, refusals and rework
Company experience
successful GMP inspections by the Authorities of the CIS
more than 2,000 successful regulatory approvals, including medicines, medical devices, food supplements, cosmetics, and food products; we have organized and supported inspections and audits:
More than 30
successful internal audits with a positive GXP, GRP and GVP conclusion
More than 50
successful quality control inspections
More than 10
Our track record
Maxim Sevostyanov
Director of Global Regulatory and Medical Translations
Education:
2015—2019 — Manash Kozybayev
North Kazakhstan University
gaukhar bilimbayeva
Chief Executive Officer (CEO), PharmD, MBA
Education:
1997—2002 — S. Asfendiyarov Kazakh National Medical University
2016—2018 — MBA, Swiss Business School, Zurich, Switzerland
dauren bilimbayev
Founder
Education:
2000—2004 — T. Ryskulov Kazakh Economic University
2003—2005 — S. Amanzholov East Kazakhstan State University
2016—2017 — NIMA International Marketing School, the Netherlands
Anna polivoda
Deputy CEO, Head
of Sales and Marketing
Education:
2018—2022 — Almaty Management University (AlmaU)
2022—2024 — Sh. Murtaza International University
gulzhan akhmetova
Head of Registration Department,
Quality Responsible Person
Education:
2005—2009 — Al-Farabi Kazakh National University
2013—2015 — K. I. Satpayev Kazakh National Technical University (KazNTU)
Bulegenova Zhadyra
Senior Registration Specialist
Education:
2008-2012 — Al-Farabi Kazakh National University (Bachelor's)
2012-2014 — S. Asfendiyarov Kazakh National Medical University (Master's)
Jenis Kamila
Registration Specialist
Education:
2016-2020 — S. Asfendiyarov Kazakh National Medical University
Asel Seidakhmetova
Senior Registration Specialist
Education:
2006-2010 — Kazakh National Agrarian University (KazNAU)
Client testimonials
Client testimonials
Frequently asked questions about the MAH QPPV service and pharmacovigilance
What does the Qualified Person for Pharmacovigilance (MAH QPPV) service include?
Registrarius Pharm Expert assumes the MAH QPPV functions: support of the pharmacovigilance system, interaction with regulatory authorities and ensuring compliance with the requirements of the MAH's country throughout the entire life cycle of the product.
Which pharmacovigilance documents do you develop and maintain?
We develop, update and maintain all necessary pharmacovigilance system documentation, including the PSMF, SOPs, PSURs, RMPs and other documents.
How does cooperation on transferring the MAH QPPV functions begin?
The first stage is signing the contract, appointing the MAH QPPV and setting up the pharmacovigilance system. The second is preparing and implementing the necessary documentation, after which the MAH QPPV functions are performed in accordance with the legislation of the MAH's country.
Do you help prepare for a pharmacovigilance inspection?
Yes. Lack of readiness for a pharmacovigilance inspection is listed among the common risks: we assess system readiness, identify potential non-conformities and support the company at all stages of the inspection.
How is the cost of MAH QPPV services calculated?
An individual commercial proposal is prepared based on the scope of pharmacovigilance services in the MAH's country, with a transparent cost calculation and no hidden fees. A free consultation and preliminary assessment of the scope of services are available.
REGISTRARIUS PHARM EXPERT office in Uzbekistan
REGISTRARIUS PHARM EXPERT office in Kazakhstan
Republic of Kazakhstan, Almaty 050000
Miras microdistrict, Tan Nury residential complex, 128, apartment 19
Sales hotline: +7 (700) 178-67-67
Mail: info@registrarius.org
Miras microdistrict, Tan Nury residential complex, 128, apartment 19
Sales hotline: +7 (700) 178-67-67
Mail: info@registrarius.org
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Guaranteed deadlines
Planning negotiations.
Contract signing
Contract signing
Handover. Project launch
Monthly reports.
Online tracking
of product statuses.
Participation in reporting meetings
Online tracking
of product statuses.
Participation in reporting meetings
Cost savings
More time for business
Lower taxes
Freeing up a staff position
Qualified managers
Focus on your business, while we take care of registration and pharmacovigilance!
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