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Registration and re-registration of medicines

We have registered more than 2000 medicines
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Registration of medicines

Registration of medicines in Kazakhstan is a multi-stage process, starting with the submission of the corresponding dossier. A dossier is a set of documents confirming the safety, effectiveness and quality of a medicinal product.

Cooperation with Adalan LLP when registering medicines provides clients with an integrated approach. Our experience, highly qualified personnel, readiness to adapt and changes in legislation make us a reliable partner on the path to introducing innovative medicines to the market.

Adalan LLP provides a range of services to support the process of registration, re-registration, and amendments to the registration dossier for medicines.

Medicines that are imported into the territory of Kazakhstan must undergo full registration with the authorized bodies for its subsequent sale in the territory of Kazakhstan.

After a medicinal product has been registered, re-registered, or changes have been made to the registration documents, the relevant information is entered into the State Register of Medicines of Kazakhstan

The procedure for conducting the examination of medicines and the timing are determined by the order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021 No. KR DSM-10 “On approval of the Rules for conducting the examination of medicines and medical devices.

Stages of drug registration

Preparation of dossier and receipt of drug samples and standard samples from the customer
Submitting an application for payment and an application to the regulatory authority
Submission and uploading of the registration dossier to the examination portal of the NC
Submission of drug samples and standard samples
Expertise (initial and specialized)
Laboratory tests (analytical)
Safety Conclusion
Submitting an application for an order
Obtaining approved documents from the regulatory authority
Our specialists will bring any project to the end, they will always tell you what strategy to choose and how to prepare the documents correctly!

Registration and re-registration of medicinal products and
medical products

Advantages of services for registration of drugs and medical devices

  • Registration of a medicinal product "on a turnkey basis", from drawing up a registration dossier to obtaining a registration certificate.

    1

  • Interact with regulatory authorities and complete all stages of registration, including responding to requests and correcting deficiencies.

    2

  • Drawing up and execution of the necessary documents for filing an application, including test reports, drug dossier, instructions for use and other documents.

    3

  • Preparing and presenting electronic and paper documentation based on specifications and methods.

    4

  • Maintenance and support after successful registration, including monitoring compliance with requirements, periodic re-registration and changes to registration documents.

    5

  • Consultations and assistance in developing a registration strategy, risk analysis and assessment of required documents.

    6
We employ specialists of the highest class who will help implement your projects!

Advantages of drug registration:

Quality
Our reputation is of great importance to us, and we are always focused on the successful completion of every project.
Support
Each member of our team has at least 5 years of experience in the pharmaceutical field.
Multidisciplinary
Our company is engaged in various fields of activity, in each of which we have achieved an outstanding professional level.
Experience
Over the course of 15 years, we have accumulated valuable experience in the field of registration and certification, we are aware of all the intricacies and take into account all the important aspects of this process.
Discount
We offer a 10% discount on initial registration.
Individual approach
We take into account the individual characteristics of each client to provide the best service and approach.
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Our services:
REGISTRATION of drugs
A full range of services to support the process of registration, re-registration, and changes to the registration dossier for medicines.


REGISTRATION of medical devices and medical devices
Comprehensive support for the process of registration, re-registration and updating of the registration dossier for medical devices and medical equipment in the Eurasian Economic Union (EAEU).
Marketing
Providing comprehensive marketing services and representing the interests of the manufacturer at the regional level.


PHARMACOVIGILANCE
Providing a wide range of services for marketing authorization holders and pharmaceutical factories in the field of pharmacovigilance and product quality control.

Price formation
Professional assistance in setting wholesale and retail prices for medicines and medical products within the framework of the guaranteed volume of free medical care.
Safety and quality assessment
A set of measures aimed at confirming the quality and safety of products.



Would you like to know the price for drug registration?

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Our presence in other countries
We represent the interests of foreign companies in Kazakhstan, Belarus, Kyrgyzstan, Azerbaijan, Georgia, Armenia, Uzbekistan, Tajikistan, Mongolia and Turkmenistan, in other countries of the EAEU and the CIS.

We will check the availability of all documents required for registration of medicines

Free consultation upon first registration
Contacts
+7 727 269 24 59;  +7 727 269 54 18
adalan.kz@adalan.kz; info@adalan.kz
050057, Republic of Kazakhstan,
Almaty, Timiryazev St., 42k23; office 202
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