GEORGIA
REGISTRATION OF MEDICINES IN GEORGIA
You’ve come to the right place. Registrarius Pharm Expert will guide your product through the entire regulatory pathway – from registration dossier preparation to obtaining the marketing authorization. We structure the process to minimize deficiencies, rework and delays.
With over 20 years of experience, we have completed more than 2,000 successful registrations of medicines, medical devices, food supplements, cosmetics, and food products.
Free initial consultation and cost estimate – we will answer all your questions and calculate the project budget through any communication channel convenient for you
Founder of Registrarius Pharm Expert
Our experience in the registration of medicines is backed by proven procedures and realistic timelines. Only working solutions, no inflated promises.
Timelines depend directly on how quickly the manufacturer provides the complete package of documents, reference standards and samples, and we, in turn, shorten them by giving the manufacturing site precise and clear requirements from the outset.
- Certified translation of the instructions for medical use into Georgian
- Preparation of the administrative part of the dossier in Georgian
- Notarization of dossier sections and preparation of the application for state registration
Duration – from 1 to 12 months
Duration – up to 14 days for submission, up to 4 months for examination and registration*
*excluding clock-stops (time for addressing deficiency letters).
Including clock-stops – up to 6 months
and ways to overcome them
We work so that, after the project is completed, you will want to recommend us to colleagues and partners. Every marketing authorization, every completed stage, is a contribution to the Company name we build painstakingly and meticulously, year after year.
The cost of a mistake is months of lost time and a derailed product launch. We understand this and therefore work with full responsibility for every stage and every document.
Deception, failure to deliver, or shifting responsibility are absolutely unacceptable to us. We take on a project only when we are confident that we will see it through to a successful outcome in the shortest possible timeframe.
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
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)
Frequently asked questions about the registration of medicines in Georgia
How long does it take to register a medicinal product in Georgia?
Up to 14 days are allowed for submission and up to 4 months for examination and registration, excluding clock-stops. Including the time for addressing deficiency letters, the timeline is up to 6 months.
Which authority registers medicines in Georgia?
The documents, reference standards and samples are submitted to the Regulation Agency for Medical and Pharmaceutical Activities of Georgia. Based on the registration decision, the Agency issues the marketing authorization, and the data are entered in the departmental register of pharmaceutical products.
What stages does the examination of a medicine in Georgia consist of?
The examination takes place in two stages: an administrative examination (verification of the completeness of the dossier) – up to 14 days, and a scientific and technical examination, following which a decision on registration is made within 3 months.
What happens if the experts' deficiencies are not resolved during registration in Georgia?
Up to 2 months are allowed to address deficiencies. The Agency notifies of deficiencies no more than twice, and if they are not fully resolved within 2 months, it refuses registration, so it is important to give complete responses the first time.
How long is the registration of a medicine in Georgia valid, and which documents are required in Georgian?
Registration is valid for 5 years and grants the right to import and market the product in the territory of Georgia. A certified translation of the instructions for medical use and the administrative part of the dossier are prepared in Georgian.
Miras microdistrict, Tan Nury residential complex, 128, apartment 19
Sales hotline: +7 (700) 178-67-67
Mail: info@registrarius.org
Contract signing
Online tracking
of product statuses.
Participation in reporting meetings