LABMGMU in the Republic of Kazakhstan

LABMGMU Representation
in the Republic of Kazakhstan

International Contract-Research Organization

Our mission is to develop and improve the methods of studies to launch effective and safe medicinal products and food supplements in the EEU market

Our Services

Good practice-based, properly regulated. Our company provides a full range of services to pharmaceutical companies in the field of preclinical and clinical studies

Marketing authorization of medicinal drugs, medical devices, nutritional products and food supplements

End-to-end service is provided according to the EEU regulations and local regulatory requirements of the Republic of Kazakhstan.

We provide support at any stage of marketing authorization:

- Analysis of the information available;
- Writing modules;
- Preparation of a dossier according to the CTD format

- Analysis and preparation of technical documents;
- Preparation of a dossier according to the CTD format
- Interaction with test laboratories, support of the expert evaluation process;
- Carcinogenic properties;
- Marketing authorization process management, including communication with authorized bodies.

All the activities are based on the EEU Resolution of November 3, 2016 No 78 On the Registration and Expert Evaluation Requirements for Medicinal Drugs for Human Use. Any other EEU country can be considered a recognition state. Documentation can be prepared in Russian, English or Kazakh as required.

Preclinical Trials

Can be prepared in Russian, English or Kazakh as required.

- Pharmacodynamic (efficacy) study
- Allergizing potential
- Immunotoxic potential
- Carcinogenic potential
- Reproductive toxicity
- General toxicity
- Mutagenic potential
- Pharmacokinetic studies

- Translation and adaptation of reports to meet the current regulatory requirements
- Engagement of opinion leaders
- Review and expertise of studies and documentation according to the EEU requirements
- Monitoring and audits of laboratory sites to ensure they meet the EEU GLP requirements
- Preparation and publication of scientific papers based on preclinical trial results

International and Local Clinical Trials in the Republic of Kazakhstan

Performed according to the international requirements (EMA, FDA), EEU rules and local regulatory requirements. Documentation can be prepared in Russian, English or Kazakh as required.

Performed according to the international requirements (EMA, FDA), EEU rules and local regulatory requirements. Documentation can be prepared in Russian, English or Kazakh as required.

We prepare documents of the following types:
- Clinical study protocol
- Synopsis
- Clinical and Preclinical Reviews and Summaries
- Investigator Brochure
- Patient/Volunteer Information Leaflet
- CRF (Case Report Form)
- Diaries, questionnaires, patient cards
- End-to-end report preparation, including data management and biostatistics sections
- Preclinical and clinical study dossier in the EEU CTD format

We engage clinical sites in Kazakhstan, Uzbekistan, Armenia, Georgia, Azerbaijan, Belarus, Russia in clinical trials. The trial monitoring and management is performed by head office and/or representative office team.

We conduct clinical studies of the following types:

- Medicinal drugs
- Food supplements
- Medical devices
- Nutritional products
- Cosmetic products

Performed according to the EEU regulations and local regulatory requirements. We perform the following activities:

1. Preparation of documents for clinical testing and observation program. Documents are prepared in Russian / English and can be translated to the Kazakh language as required.

2. Organization and management of clinical studies of food supplements.

3. Preparation and publication of scientific papers for a specific food supplement.

We prepare papers for publication in Kazakh, international or Russian journals according to the specific editorial requirements.

eCRF in Russian/English, with a translation into Kazakh, as required.

Performed on the basis of the individually designed eCRF.

Performed according to ICH GCP.

Bioequivalence studies

Performed according to the international requirements (EMA, FDA), EEU and local regulatory requirements. Documentation is prepared in Russian/English. A translation into Kazakh can be performed as required.

Performed according to the international requirements (EMA, FDA), EEU rules and local regulatory requirements. Documentation can be prepared in Russian, English or Kazakh as required.

We prepare documents of the following types:
- Clinical study protocol
- Synopsis
- Medicinal Drug Reviews and Summaries
- Investigator Brochure
- Patient/Volunteer Information Leaflet
- CRF (Case Report Form)
- Diaries, questionnaires, patient cards
- End-to-end report preparation, including data management and biostatistics sections
- Preclinical and clinical study dossier in the EEU CTD format

eCRF in Russian/English, with a translation into Kazakh, as required.

Performed on the basis of the individually designed eCRF.

Performed according to ICH GCP.

User Acceptance Testing

We perform a user acceptance testing of the drug information leaflet in Russian and in Kazakh.

International audit, preparation for regulatory inspections, organization and implementation of quality assurance and control program in the Republic of Kazakhstan

The audit is performed by the quality assurance and control team of the head office in person, in the remote or in a mixed format.

LABMGMU performs:

Audits of the study sites, clinical trials, contract research organization or the study sponsor.
Preparation for inspections of the EEU regulatory organs.
Organization and implementation of the quality assurance and control system, including preparation of SOP.

We successfully passed
independent international audit

Advanced Professional Education

Advanced training certificates issued by the LABMGMU training center, according to Federal Law No 273-ФЗ dated December 29, 20`1 On Education in the Russian Federation are official academic certificates. The authenticity of the certificate can be confirmed in an electronic register of the documents issued.

License No 039799 dated December 18, 2018.

Training certificates are also valid in the territory of the Republic of Kazakhstan. Basis: Agreement on mutual recognition of training documents between the Republic of Kazakhstan and the Government of the Russian Federation

We offer remote training for the following courses:

"Good Clinical Practice ICH GCP"

"Dissolution test in the medicinal product development and marketing authorization"

"Mathematical Statistic Fundamentals in the CT Practice"

Please refer your questions to the LABMGMU Manager in Kazakhstan

*By filling this form, I agree with the personal data processing conditions