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Pharmacovigilance

There are 1,500 medicines and 470 medical devices under pharmacovigilance supervision.

Pharmacovigilance

Pharmacovigilance is an important component of healthcare and is intended to protect the public from substandard or dangerous drugs.

Pharmacovigilance is “the science and activities related to the detection, assessment, understanding and prevention of adverse reactions or any other problems associated with drugs”

(ВОЗ)

"Pharmacovigilance of medicines is a system of monitoring, analysis and evaluation of information on the safety of registered medicines"

Code of the Republic of Kazakhstan "On the health of the people and the healthcare system"

A range of services for owners of reactor plants and pharmaceutical plants regarding pharmacovigilance:

Supporting testing of product samples through selection from the market;
Supporting the inspection of the pharmacovigilance system of the DRU;
Supporting the process of assessing the benefit-risk ratio of medicines and medical devices;
Translation of documents for the pharmacovigilance system;
Working with cards - messages;
Preparation of a safety report for the drug under development (DSR);
Preparation of periodic safety report (PSAR);
Preparation of a risk management plan (RMP);
Development of SOPs for the pharmacovigilance system;
Master file development;
Monitoring open literature sources in order to collect information on adverse reactions;
Preparation of literature reviews on drug safety, searching for information on websites;
Collection, processing and transmission to the head office of partners and to Regulatory Authorities of information about adverse events during the medical use of the company’s product (ICSR);
Monitoring side effects of drugs; medical products and medical equipment.
Preparation and submission of periodic drug safety reports (PSR) to Regulatory Authorities
Preparation and submission of reports of serious adverse events (CIOMS) to the Regulatory Authorities, coding of spontaneous consumer requests, entering information into the pharmacovigilance database;
Providing advisory services;
Tracking changes in legislation and much more...

Advantages of pharmacovigilance for drugs 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

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

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.

TRADEMARK REGISTRATION

Turnkey trademark registration, full support. All stages of the registration procedure, from registration and submission of an application to receipt of a registration certificate.

Safety and quality assessment

A set of measures aimed at confirming the quality and safety of products.

Do you want to know the price of pharmacodasor drugs 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.