THE REPUBLIC OF MOLDOVA
REGISTRATION OF MEDICINES IN THE REPUBLIC OF MOLDOVA
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.
- Translation of the summary of product characteristics (SmPC) and the patient information leaflet into Romanian
- Preparation of the registration application and pharmacovigilance documents, including details of the responsible person in the Republic of Moldova
Duration – from 1 to 12 months
Duration – up to 14 days for submission, up to 210 days for examination and registration / 7 months*
*excluding clock-stops (time for addressing deficiency letters).
Including clock-stops – up to 360 days / 12 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 Moldova
How long does the registration of a medicinal product in Moldova take?
Up to 14 days are allowed for submission and up to 210 days for examination and registration, excluding clock-stops. Including the time for addressing deficiency letters, the timeline is up to 360 days.
Is laboratory control of samples performed during registration in Moldova?
Laboratory control of samples is performed after a positive conclusion on quality. For products approved by the EMA, as well as for products from manufacturing sites inspected by regulators of PIC/S countries, laboratory control is not performed.
Who decides on the registration of a medicine in Moldova?
The results of the examination are reviewed by the Medicines Commission, which may order an inspection of the manufacturing site if necessary. Based on its decision, AMDM issues an authorization order, and the product is included in the State Nomenclature of Medicines.
What deadlines apply to responses to AMDM deficiency letters in Moldova?
30 days are given to supplement the documents during the completeness check, and 90 days to respond to deficiency letters. If the deficiencies are not resolved after two consecutive notifications, the authorization procedure is terminated.
Which documents need to be prepared for the registration of a product in Moldova?
A registration dossier in CTD format, reference standards and samples are collected. To meet AMDM requirements, the SmPC and the patient information leaflet are translated into Romanian, and the application and pharmacovigilance documents are prepared, including details of the responsible person in the Republic of Moldova.
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