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Assessing the benefit-risk ratio

Ensuring the protection of public health and improving patient safety

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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:

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 assessing the benefit-risk ratio of medicines and medical devices?

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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.