+38 044 332-42-94,
+38 044 221-71-29, info@cratia.com.ua
+38 044 221-71-29, info@cratia.com.ua
Cratia is Ukrainian commercial independent company established in 2005 by group of regulatory experts. Aim of the company was to unite experience and knowledge of several specialists in regulatory affairs on medicinal products. Starting from 2006 company has also started to provide services of marketing authorization of medical devices and equipment, special food products and cosmetics.
From 2007 Ukraine is represented by Cratia in worldwide regulatory database Tarius. From 2009 Cratia is a member of European Business Association.
Company's portfolio includes more than 700 registered medical devices, more than 350 medicinal products, active substances and medicinal immunobiological products, more than 250 food supplements and cosmetics. We have translated app. 71 200 pages (128 160 000 symbols) of medical and chemical-pharmaceutical documentation, notary certified translations of app. 7 700 documents, printed approximately 4 275 000 pages of registration dossiers from the date of establishment till the end of 2011. We have prepared more than 700 AND (control methods of finished product), 770 package inserts, 2050 package mock-ups for medicinal products.
Our success is granted by outstanding team of professionals that have necessary knowledge and experience to provide our customers with exclusive regulatory support.
Our team:
| Medicinal products department: | |
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Natalia KINDURIS, Deputy director |
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Marina KOZLOVA, Head of the department |
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Dmitry ANDRYUSHIK, Regulatory affairs expert |
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Marina LESYK, Regulatory affairs expert Higher chemical-technological degree, chemist of 1st category. More than 7 years of quality control laboratory work and more than 4 years in regulatory affairs. Excellent chemical English and strong knowledge of Ukranian and international legislation. |
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Natalia PARASCHENKO, Regulatory affairs manager Higher pharmaceutical degree. More than 5 years of experience in regulatory affairs on medicinal products. |
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Volodymir ILCHENKO, Regulatory affairs manager, design editor Higher pharmaceutical degree, excellent knowledge of graphical programs and printing technologies. |
| Medical department: | |
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Valeriya SYCHOVA, Ph.D., Medical Director Higher medical degree, Ph.D. in "Virosology and immunology", doctor of I category, author of 25 scientific works. Exclellent knowledge of professional English, more than 20 years of experience in medicine and regulatory affairs. |
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Alla PASTYCH, expert of Medical department and GMP specialist Higher medical degree in biophysics, scientific works in neurophysiology and biophysics, more than 15 years of experience in applied biophysics. More than 5 years of work in state authorities of MoH in licensing and certification of manufacturing sites. Certifcate of GMP training. |
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Oleg MAZURENKO, expert-clinicist, editor Higher medical degree, excellent medical and technical English. More than 12 years of editorial experience in medical area. Being an editor has prepared more than 300 articles (weekly magazine "Apteka", magazine "Health of Ukraine", magazine "Heart Failure"). |
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Tatiana MALINOVSKAYA, expert-clinicist, editor Higher medical degree. More than 20 years of medical practice, 7 years of scientific practice, scientific publications on clinical immunology and oncology. More than 13 years of experience in IVD laboratory practice, virologist doctor of II category. |
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Yulia REKHLIS, specialist translator, editor Higher philological education, diploma of English and German translator. More than 3 years of experience in medical area. |
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Medical devices department: |
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Ekaterina BURBEZA, Head of the department Higher degree in physical biomedical electronic. Diploma of TUV training on Medical Device Directive 93/42/EEC and ISO 13485, certificate of internal auditor for ISO 9001. More than 7 years of experience in marketing authorization of medical devices. Managing and supervision of all regulatory processes on medical devices. |
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Alexander BOGAY, expert of medical devices department Higher degree in certification and standartization. Excellent knowledge of English. More than 3 years of experience in marketing authorization of medical devices.
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Andrew COMPANIETS, regulatory affairs manager Higher degree, specialist on quality, standartization and certification. Excellent knowledge of English, training and experience on GMP compliance. Experience in regulatory affairs more than 2 years. |
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Darya SIVENOK, regulatory affairs manager Higher degree in industrial biotechnological research and development. Excellent knowledge of English, exeprience in filling of Application for regulatory submissions. |
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Department of special food products and cosmetics |
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Elena MARCHENKO, Head of the department Higher education in law, excellent knowledge of English. More than 5 years of experience in regulatory affairs. More than 3 years of experience of marketing authorization and certification of special food products and cosmetics. |
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Galina POLUHINA, expert of the department Higher radiophysical degree, high knowledge of English. More than 4 years of experience of marketing authorization and certification of special food products and cosmetics. |
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Jenya ANDRUSHENKO, expert of the department Higher degree in certification and standartization. Excellent knowledge of English. More than 3 years of experience in regulatory affairs.
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| Administrative department | |
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Sergey LIKHENKO, administrative assistant Higher technical degree, excellent knowledge of Adobe Illustrator, Adobe Photoshop, Corel Draw. Experience with edition of package labeling more than 5 years. |
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Mariya SCHERBENKO, Administrative assistant Higher degree, excellent knowledge of English and experience in business organization. |
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Alexandr MOSKALENKO, Senior customs expert Higher technical education (metrology and measuring devices) and economy education, certified customs broker. Experience in custom clearance of medical goods more than 12 years. |
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Oksana DATSYUK, customs expert and lawyer Higher education in law, more than 10 years of experience in export-import operations, excellent knowledge of international and local customs legislation and practical experience in logistics. |
| Top management | |
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Max BAGREEV, CEO (General Manager) Higher financial education, higher education in law. Excellent knowledge of English, experience in regulatory affairs more than 7 years. More than written 200 pages of articles on regulatory themes, excellent knowledge of ukrainian and international legislation. |
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Irina BURTSEVA, Executive Manager Higher financial education. Excellent knowledge of English, experience in top management in regulatory affairs more than 10 years. Excellent knowledge of ukrainian and international legislation. |
You can contact us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting in our office.