NEWS & PROMOTIONS
Since 30.10.2017, the obligatory provision for applicants in drug registration and re-registration is to provide a Risk management plan (read more details in sеction Pharmacovigilance) and clinical data addenda (DCRA, see more details in section Drug clinical review addendum (DCRA). Nowadays, a 2-year transitional period is provided to applicants for preparation of the documents. Up
Our company provides services on conduct of clinical studies with the use of modern diagnostic methods such as: — computerized tomography; — contrast computerized tomography; — magnetic resonance imaging; — ultrasonic diagnostics. We offer a competitive price for a complex examination of patient groups in various phases of clinical studies. As well, you may have
Since January 2017, the Ukrainian Ministry of Health will carry out inspections of compliance with the license conditions for medical practice in accordance with the decree of the Ukrainian Cabinet of Ministers №285 dated 02.03.2016. Firs medical centers which fall under inspections – those which do not comply with the licensing conditions in relation to:
ABOUT THE COMPANY
“Scientific license center» – a scientific – consultation center on registration and certification of products and services in Ukraine. Specialists of our company will not only consult you on execution of approval documents but also will say how to minimize correctly the number of documents hereby optimizing an enterprise expenses. As well, we will help to select a certification, licensing scheme most appropriate for your business, will say which should be considered, and what pitfalls are when you open an enterprise in areas: medicine, pharmaceuticals, grocery, food and agricultural industries, etc.
Our specialists will also help you in a product customs clearance (export, import) and will preliminarily tell which documents are required for that. As well, we will help you to determine a product according to the Ukrainian or European classification of customs tariffs, confirm a price stated in an invoice. We have been working already over 10 years providing services in licensing, certification of products and services.
During all this period, we earned the reputation of the company with a high level of professionalism and competence, the leading industrial, medical, pharmaceutical enterprises have become our constant clients. Therefore collaborating with us, you minimize your financial expenses and powers, and as a result you will get approval documents executed in due terms.
We provide the following services:
2. Accreditation of medical institutions – execution of an accreditation certificate after three-year activity of an enterprise since the receipt of a medical practice license.
3. License on pharmacies (pharmacy warehouse) – execution of an approval for pharmacy activity.
4. Drug import license – execution of an approval which necessary for customs execution of drugs imported to Ukraine.
5. Wholesale drug license – necessary to drug manufacturers or large distributors for drug sales to pharmacies.
6. License on narcotic drugs, precursors – permit for access and handling with narcotic drugs and precursors. It is necessary for medical institution having an anesthesiology, surgery unit, laboratories, educational institutions for conduct of studies using precursors as solutions, reagents.
7. Drug registration in Ukraine (or CIS) – a process of studies and official execution of a marketing authorization for sales in Ukraine.
8. Registration of medical devices (medical equipment) – execution of a technical regulation for a product sales in Ukraine.
9. Registration of insecticides, disinfectants, repellents – conduct of toxicological biological tests to execute a state registration certificate.
10. Registration of cosmetic products – conduct of a state sanitary and epidemiological expertise to execute SES conclusion.
11. Registration of biologically active additives – a process of SES approval execution for successful sales of the product in Ukraine.
12. Development and registration of TS –a process of development and registration of technical specifications in Ukraine.
13. Development of a composition of disinfectants, biologically active additives, drugs – conduct of research studies of development of an optimum composition for disinfectants, biologically active additives or drugs.
14. Drug clinical review addendum – a conclusion of an independent practicing expert that a drug demonstrates benefit rather than risk in is medical use.
15. Preclinical studies on medical devices, drugs, biologically active additives – conduct of studies on animals to confirm safety of a medical device, dietary supplement or a drug.
16. Clinical studies on medical devices, drugs, biologically active additives – a process of studies on humans to confirm safety and efficacy of medical, drugs, biologically active additives.
17. Pharmacovigilance – services on development of pharmacovigilance system, PSUR, DSUR, DCRA.
18. Sanitary and hygienic conclusions on products – conduct of a state epidemiological expertise to execute an approval of product sales in Ukraine.
19. Sanitary and hygienic conclusions on premises –examination and execution of premises inspection certificate in accordance to SES standards and licensing conditions.
20. Conclusions of the Trade –Industrial Chamber on determination of Ukrainian customs tariff code, European customs tariff code – determination of a product code in accordance with the 2 classifications.
21. Customs clearance of commodities (import, export) – execution of customs clearance of commodities for export or import.
We will be glad to every your call and give a good quality consultation on any abovementioned services.
We
are a team of responsible and professional people
WORKING
saving your time and means
RESULTS
100% of the receipt of documents on the specified dates
OUR DOCUMENTS
REVIEWS
Vinmedikal: "We have been working with this company since 2013, we issued all sorts of permits: registration of medical equipment, letters of confirmation of registration. Over the years of work, they proved themselves as a reliable partner, fulfills contractual arrangements for processing documents on time."
MC Nikomed: "We issued a license for medical practice: the company"s specialists clearly explained what is necessary for the opening and successful operation of the medical center." We were very pleased with the services provided. "
MC Polla: "We issued a license for medical practice and consulted about the successful passage of accreditation." The company"s services were satisfied."
OUR CLIENTS