Services
The consumer goods industry
Partner in Kazakhstan
160000, Kazakhstan, Shymkent, Tole Bi str. 26, building 2, offices 106 - 111.
Head Office
100027, Uzbekistan, Tashkent, Beshyogoch Square, 22.
The information system is designed to
Automation of regulatory body processes on procedures:
- Registration (renewal of registration, changes and additions to registration documents) of pharmaceuticals, medical equipment and medical devices.
- Certification of pharmaceuticals, medical equipment and medical devices.
- Reference pricing of medicinal products.
- Registration (renewal of registration, changes and additions to registration documents) of pharmaceuticals, medical equipment and medical devices.
- Certification of pharmaceuticals, medical equipment and medical devices.
- Reference pricing of medicinal products.
The system implements modules:
The module "Registration of drugs, MT, medical devices" supports processes below:
- Filing and reviewing the application
- Sending and accounting of registration samples
- Calculation of service cost
- Examination of the electronic dossier
- Production inspection
- Clinical trials
- Laboratory Research
- Presidium Committees
- Expert Council
The module "Certification of medicines, medical devices" supports processes below:
- Submission and review of the application
- Decision on certification
- Medical product identification, selection and record keeping
- Production inspection
- Laboratory examinations
- Decision to issue or refuse to issue a certificate of conformity
The module "Referential pricing" supports processes below:
- Submitting an application
- Review of application
- Registration/re-registration of the limit price
The product also implements other modules such as:
- Laboratory
- GMP (GxP)
- Clinical trials of drugs, MT, IMN
- Presidium
- Expert Council
- Warehouse Operations
- Guides
- Integration
- Reports
The system is built taking into account
1
Laws and decrees of the Republic of Uzbekistan government regulating the pharmaceutical industry in the country
2
Internal general regulations and practices of SUE "State Center for Expertise and Standardization of Medicines, Medical Devices" and structural subdivisions (Committees, laboratories, and departments)
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