+7 727 269 54 59


Assessing the benefit-risk ratio

Ensuring the protection of public health and improving patient safety

Supporting the process of assessing the benefit-risk ratio of medicines and medical devices

Medicines that have an indefinite registration

Stages of benefit-risk assessment

1
Coordination of the list with the marketing authorization holder (MAH)
2
Conclusion of an agreement with the regulatory authority
3
Submitting an application for the service
4
Payment assistance
5
Submission of safety profile information to the regulatory authority
6
Obtaining an expert opinion

Advantages of assessing the benefit-risk ratio of medicines and medical devices:

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.
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!
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Our services:
A full range of services to support the process of registration, re-registration, and changes to the registration dossier for medicines.


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).
Providing comprehensive marketing services and representing the interests of the manufacturer at the regional level.


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

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



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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 prepare and submit all reports to the regulatory authority - PSUR, RMP, CIOMS.

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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+7 (727) 269 54 59