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RegiCom company was established in 2008. Our main areas of activity are to render services for registration of pharmaceutical products, registration of medical devices, medical equipment, execution of licenses for pharmaceutical activity; execution of permit for the import of products; registration of cosmetic products, registration of BAAs, registration of baby food, and sports supplement. RegiCom is official company on the registration, certification and metrology. The website’s of our company is the official website.
RegiCom Company is a friendly, close-knit team, which provides a high level of our efficiency and competitiveness in the market. The quality of our company registering is the highest.
Experts of our company are experienced managers who have solid bundle of knowledge, skills, and successful projects. We are always ready to support your business with our services.
The high quality of our work is appreciated by our customers, including most of the leading Russian and international pharmaceutical companies.
Registration in Kazakhstan and the countries of Asia, Russia and Europe.
| 1 | Signing a confidentiality agreement |
| 2 | Examination of the submitted documents, giving to the applicant the status of documents, request the missing documents; calculation of the number of samples and standards for analytical examination, calculation of the cost of our services, inclusive of all the additional work to prepare the registration dossier (IDA development, translations, etc.); calculation of the overall preparation of the dossier and aggregate term of registration. |
| 3 | Conclusion of a contract for services |
| 4 | Formation of the registration dossier. Development of analytical-normative document (IDA), the drafring of instructions for medical use, the development of labeling in Russian and Kazakh languages. |
| 5 | Execution of the contract between the Applicant and the National Center for medicines, medical devices and medical equipment Expertise of Ministry of Health of the Republic of Kazakhstan. |
| 6 | Obtaining of permits to import samples of the pharmaceutical products and the organization of import procedures and customs clearance. |
| 7 | Filing of documents for the registration dossier, samples and standards to the National Center for medicines, medical devices and medical equipment Expertise of Ministry of Health of the Republic of Kazakhstan. |
| 8 | Receipt of invoice for payment of examination in the National Center for medicines, medical devices and medical equipment Expertise of Ministry of Health of the Republic of Kazakhstan. |
| 9 | Maintenance and monitoring at all stages of registration, compliance with comments; |
| 10 | Agreed with the customer IDA projects, instructions for medical use, layout packages |
| 11 | Obtaining the original registration certificates and normative documents and send them to the Customer; The term of the initial examination of the documents submitted - 1-3 days. The term of preparation of documentation for submission to the Government authorities 7- 15 working days. |
