Preparation of the dossier in the national procedure and within the EAEU, all procedures, for consideration by the authorized bodies for new registration/re-registration/amendments. Work with layouts for new products, (Labeling). Collection of registration dossier for drugs. Submitting dossier to NDDA. Negotiating and correspondence with NCED, DCC MFD on registration issues. Elimination of discrepancies in the registration dossier, control at all stages of registration on the website.

The SFE is regulated by the Orders of the Ministry of Health and Social Development of the Republic of Kazakhstan dated November 18, 2009 No. 735 and No. 736. Quality assessment of drugs is carried out on the basis of the State Pharmacopoeia of the Republic of Kazakhstan, аs well as current editions of pharmacopoeias, of which the European, British Pharmacopoeias, the US Pharmacopoeia, the German Homeopathic Pharmacopoeia are recognized as valid in the Republic of Kazakhstan. In a comparative analysis of the quality of medicines, the Chinese and Indian Pharmacopoeias are considered as national standards of the leading world pharmaceutical manufacturers, as well as the Japanese Pharmacopoeia, the standards of which are harmonized at the International Conference on the Harmonization of Technical Requirements for Registration of Medicines (ICH) and differ in the most stringent quality requirements Drugs. In addition, the founding documents for the SFE are WHO recommendations, policy documents of the European Medicines Agency (EMEA), the US Food and Drug Administration (FDA), and others. Finally, drug quality assessment is not possible without knowledge of the requirements of international and national standards. Practitioner (GLP, GMP, GDP, GPP). A specialized pharmaceutical examination of a medicinal product includes an assessment of: chemical safety and quality of the drug, the impact of changes to the registration dossier on the safety, effectiveness and quality of the drug; the composition of the medicinal product and the conclusion on its rationality, the quality of medicinal substances and excipients; production of a medicinal product (production formula, production technology, control during the production process, validation of production processes); finished product (compliance of the parameters specified in the quality certificate for finished products with the described quality control procedures in the regulatory and technical document for the quality control and safety of medicines, analysis of the test laboratory report, assessment of the possibility of reproduction and objectivity of quality control techniques, the adequacy of the composition of the drug and quality control procedures)

1. Statement of tasks and organization of execution. 2. Distribution of duties. 3. Providing interaction. 4. Building up interpersonal relationships. 5. Analysis of the results. 6. Audits process efficiency.

The SFE is regulated by the Orders of the Ministry of Health and Social Development of the Republic of Kazakhstan dated November 18, 2009 No. 735 and No. 736. Quality assessment of drugs is carried out on the basis of the State Pharmacopoeia of the Republic of Kazakhstan, as well as current editions of pharmacopoeias, of which the European, British Pharmacopoeias, the US Pharmacopoeia, the German Homeopathic Pharmacopoeia are recognized as valid in the Republic of Kazakhstan. In a comparative analysis of the quality of medicines, the Chinese and Indian Pharmacopoeias are considered as national standards of the leading world pharmaceutical manufacturers, as well as the Japanese Pharmacopoeia, the standards of which are harmonized at the International Conference on the Harmonization of Technical Requirements for Registration of Medicines (ICH) and differ in the most stringent quality requirements Drugs. In addition, the founding documents for the SFE are WHO recommendations, policy documents of the European Medicines Agency (EMEA), the US Food and Drug Administration (FDA), and others. Finally, drug quality assessment is not possible without knowledge of the requirements of international and national standards. Practitioner (GLP, GMP, GDP, GPP). A specialized pharmaceutical examination of a medicinal product includes an assessment of: chemical safety and quality of the drug, the impact of changes to the registration dossier on the safety, effectiveness and quality of the drug; the composition of the medicinal product and the conclusion on its rationality, the quality of medicinal substances and excipients; production of a medicinal product (production formula, production technology, control during the production process, validation of production processes); finished product (compliance of the parameters specified in the quality certificate for finished products with the described quality control procedures in the regulatory and technical document for the quality control and safety of medicines, analysis of the test laboratory report, assessment of the possibility of reproduction and objectivity of quality control techniques, the adequacy of the composition of the drug and quality control procedures)

Analytical examination of a medicinal product includes: 1) physical, chemical, physico-chemical and biological tests of drug samples for compliance with the requirements of the regulatory technical document for monitoring the quality and safety of drugs; 2) an assessment of the normative and technical document for the control of the quality and safety of medicines for the reproducibility of analysis methods.