About "Cratia"

Cratia is a group of companies, which provide professional regulatory services on registration (marketing authorization), safety and quality management of medical products across Ukraine and CIS countries. The company is focused on medicines, medical devices and equipment, food supplements, disinfectants and cosmetic products.

Our work greatly facilitates access to the most modern and high-quality medical products.

Company’s portfolio includes:

more than 80 manufacturers of medicines and active substances,
more than 500 manufacturers of medical devices and equipment,
more than 200 manufacturers of food supplements and cosmetic products.

Cratia does not deal with distribution and marketing, is not associated with government officials, politicians and parties. We do not allow conflicts of interest, value any partner equally, follow the code of business conduct and strictly observe confidentiality. We strictly comply with local and international legal requirements, representing manufacturers in the competent authorities.

History:

“Cratia” was founded in 2006 by a group of regulatory specialists.

Cratia has been a member of the European Business Association since 2009, the Association of Market Operators of Medical Devices since 2012 and the American Chamber of Commerce in Ukraine since 2013.

In 2015, a positive opinion was received on the results of the PSCI audit (Pharmaceutical Supply Chain Initiative).

In 2016, quality management system to meet the requirements of ISO 9001:2015 was certified by Bureau Veritas.

Today Cratia is a recognized expert in regulatory affairs. We are invited as speakers to WHO events, participate in working groups of the competent authorities and Associations, publish articles in national and international specialized media.

Team:

Our success is based on a great team of professionals, each of whom is an expert in their professional field, and constantly improve their knowledge and skills. Our team is growing rapidly and replenished with both full-time and freelance specialists. We all support the project, care for the client and are focused on the result.

Key Account Managers
	Max Bagreev Managing partner University degree in finance and economy, over 14 years of experience in regulatory, safety and quality for medicines and medical devices. More than 300 pages of publications on regulatory topics in the systems of Tarius, Thomson Reuters, Informa Lifescience and national specialized media. Fluent English, excellent knowledge of the regulatory legislation of Ukraine, CIS and EU.
	Irina Burtseva Executive manager University degree in finance and economic. Experience in the field of administration more than 15 years. The main responsibility in the company's activities is building of relationships with Customers and organizing the company's work.
	Alla Pastukh Head of quality affairs department Higher education in the sphere of biology, specialty - biologist-biophysicist. Professional experience of 19 years. Professional experience in recognizing / certifying the conformity assessment of production of medicines to the requirements of GMP, in controlling the quality of medicines, in conducting audits of medicines production and audits on the compliance of the elements of the quality system of an enterprise with the licensing requirements for the import and wholesale trade of medicines - 12 years. Author of a number of scientific articles; active participation in specialized seminars, trainings. Knowledge of the regulatory legislation of Ukraine and the EU.
	Nataliya Naumchuk Key Account Manager University degree in “Medical equipment engineering”, second university degree in “International economics”. Experience in development and implementation of medical devices into production more than 10 years. Excellent knowledge of English.
Department of Registration of Medicines
	Natalia Kinduris Deputy Director University degree in pharmaceutics, over 18 years of experience in registration of medicines. Excellent knowledge of Ukrainian and international legislation in the area of medicines registration. Manages the department on issues related to registration, renewal and variations and directly contacts regulatory authorities on the territory of Ukraine.
	Marina Kozlova Head of Regulatory Affairs Department University degree in pharmaceutical chemistry; over 10 years of experience working in an analytical laboratory and over 17 years of experience in registration of medicines. Maryna directs and coordinates the back-office operations.
	Dmytro Andruschyk Regulatory Affairs Specialist University degree in the sphere of chemistry and technology. Professional experience of more than 10 years in the field of quality control of medicinal products and more than 7 years in the registration of medicinal products.
	Tetiana Kuznetsova Regulatory Affairs Specialist University degree in chemistry, over 8 years of experience in a quality control laboratory and over 10 years of experience in registration of medicines.
	Olga Levchuk Regulatory Affairs Specialist Higher education in the sphere of chemistry. Professional experience of more than 10 years in the field of quality control of medicines and more than 6 years in the registration of medicines.
	Oksana Plushch Regulatory Affairs Specialist Higher education in the sphere of chemistry and technology. Professional experience of more than 2 years in the field of quality control of medicinal products and more than 5 years in the registration of medicinal products.
	Iryna Bosak Regulatory Affairs Specialist University degree in the sphere of chemistry. Professional experience of 10 years in the field of quality control and pharmaceutical development of medicines and more than 2 years in the registration of medicines.
	Natalia Hrytsenko Manager of Regulatory Affairs University degree in biotechnology, second degree in finance. PhD in biotechnology. Experience in scientific research and teaching for 10 years. Scientific publications in international journals, participation in scientific conferences.
	Oleh Kokovskyi Manager of Regulatory Affairs University degree in Pharmacy. 2 years in pharmaceutical distribution, more than 9 years in state registration of medicinal products.
	Nataliia Lipisiienko Regulatory Affairs Specialist University degree in Biotechnology. Working experience in drug regulatory affairs is more than 7 years.
Department of International registration of products
	Liudmyla Shumliak Head of International Regulatory Affairs Department Higher education in the sphere of biology. Specialty - virology, biology. Professional experience of more than 10 years. Knowledge of the regulatory legislation of the CIS countries in the field of registration of medicines, medicinal devices, special food and cosmetic products. Professional experience in the registration of medical products in the CIS region of more than 6 years.
	Mariia Glushachenko International Regulatory Affairs manager University degree in Medicine and Pharmacy. More than 9 years of experience in state registration of pharmaceutical products in Ukraine and CIS countries.
	Alona Muradova Regulatory Affairs Spesialist CIS region Master’s degree in the biology, biotechnology, genetics fields. Deep integration in the regulatory framework of CIS legislation in following the field of registration: medicines, medical devices, food supplements and cosmetic products. Great experience in the registration of medical products in the CIS countries, ASEAN countries, Australia, New Zealand.
	Yuliia Pikalova Regulatory Affairs Spesialist CIS region Higher education in the field of biotechnology and bioengineering. Practical experience in the Marketing Authorization of medicines and knowledge of the laws of the CIS countries and the Far Eastern market.
	Olga Andriushchenko Regulatory Affairs Spesialist CIS region University degree in Pharmacy and in chemical technologies. Over 7 years of experience in the field of registration of medicines, medical devices, special food supplements and cosmetic products in the CIS countries, Africa and the EU.
Medical affairs department
	Valeriya Sychova, MD Medical Director Higher education in the sphere of medicine, specialty - medical business. Candidate of medical sciences in the field of virology and immunology. Professional experience of more than 25 years, including in the medical business of more than 20 years: medical products, medicines. Author of scientific publications; regular participation in specialized trainings.
	Sergey Kireev Medical expert, editor University degree in paediatrics, paediatric neurology. Experience in medical translations for more than 20 years, including CAT-programs. Publications in specialized print media. Speaker at international scientific conferences.
	Volodymyr Kandziuba Medical expert-editor University degree in paediatrics, over 7 years of medical practice. Publications in specialized print media. Participant at international scientific conferences. Excellent knowledge of professional English.
	Viktoriia Lysytsia Medical Editor University degree in paediatrics, paediatric neurology. Work experience in the specialty for more than 30 years. Publications in specialized print media. Experience in medical translations for 5 years.
Pharmacovigilance Depertment
	Olga Ivanova Head of Pharmacovigilance Department University degree in biology, specialization – biologist-cytologist. PhD degree in medical sciences, specialization – histology, cytology, embryology. Experience in the specialty for more than 25 years (82 scientific publications, participation in scientific conferences), including in the pharmaceutical business for more than 5 years: non-clinical studies (medicines, medical device), registration, pharmacovigilance. Knowledge of the legislation of Ukraine, EAEU, EU standards concerning pharmacovigilance and registration of medicines.
	Volodymyr Kuchma Pharmacovigilance specialist University degree in medicine and pharmacology. Over 6 years in state registration of medicinal products/pharmacovigilance. Sufficient qualification and knowledge of Ukraine's legislation, rules and standards of the European Union in registration of medicinal products/pharmacovigilance.
	Igor Shklyarevych Pharmacovigilance specialist University degree in Pharmacy, master of pharmacy. Over 5 years in state registration of medicinal products / pharmacovigilance. Sufficient qualification and knowledge of international and Ukraine's legislation in registration of medicinal products / pharmacovigilance. Publications, participation in scientific conferences.
	Maryna Mykhailiuk Pharmacovigilance specialist More than 3 years in the field of pharmacovigilance. Knowledge of the legislation of Ukraine, EAEU, CIS, EU standards concerning pharmacovigilance.
Department of product quality management, standardization and certification of production
	Daria Ponomarova Quality Specialist University degree in veterinary medicine. Second degree in «Quality, standardization and certification». Кnowledge of regulatory requirements in quality control and GMP-certification areas. Experience in the pharmaceutical industry more than 4 years.
	Ekaterina Gritsaenko Quality Specialist University degree in Pharmacy. Master on speciality “Quality, standardisation and certification of the production and services”. Experience in pharmaceutical branch is more than 8 years, from which in the domain of licensing and certification are more 3 years.
	Anastasiia Koval Quality Specialist Higher education in the field of Biotechnology and bioengineering.
Medical devices certification and conformity assessment department
	Alla Somyk Head of compliance assessment department University degree in engineering. Expert in certification of national manufacturing of products. Experience in this field more than 10 years.
	Alina Ermak Head of Authorized representative department University degree in biotechnology. Master's degree in “Quality, standardization and certification”. Professional experience in the microbiological laboratory of more than 3 years. Professional experience in the regulatory sphere of more than 2 years.
	Victoria Moroz Specialist on standardization, certification and quality Qualification of higher technical education in biotechnology and bioengineering. Competence in educational projects “Processes, devices and equipment of industries” and “Bioinformatics”. Expert in the specialization of molecular biotechnology.
	Valentyna Pobiedina Junior specialist of Certification and Conformity Assessment Department Master Degree in Laser Optics, Physics Department, Kyiv National University. Research articles, participation in international conferences.
	Anna Hnatiuk Specialist of Certification and Conformity Assessment University degree in "Biomedical engineering". The author of scientific publications; participation in international scientific conferences.
	Yuliya Vertyaeva Specialist of Certification and Conformity Assessment University degree in Quality, Standardization and Certification.
	Daria Kustovska Specialist of Certification and Conformity Assessment Master's degree in "Medical equipment engineering". Research articles, participation in international conferences.
FMCG
	Inna Kapytsia FMCG department Specialist University degree in biotechnology. Knowledge of regulatory requirements in registration of dietary supplements and cosmetics. Over 3 years of experience in chemical laboratory, experience in registration of dietary supplements and cosmetics is 1 year.
	Alina Ivaniuk FMCG department Specialist Higher technical education in the sphere of "Biotechnology". Knowledge of regulatory requirements in the field of cosmetics and dietary supplements. Professional experience in the microbiological laboratory.
Design and prepress department
	Yuri Vasiliev Head of design and prepress department University degree in medicine. Perfect knowledge of graphics software and printing technologies. Experience in printing industry - 18 years. Over 5 years of experience in regulatory affairs. Languages: Ukrainian, Russian, English.
	Aleksey Suslin Designer, Editor Higher technical education. Outstanding knowledge of graphics software and printing technologies. Over 10 years of experience in printing industry. Over 3 years of experience in regulatory affairs. Languages: Ukrainian, Russian, English.
	Olesja Panchenko Designer University degree in Biology, second degree in Art. Perfect knowledge of graphics software. Experience in design industry - 10 years. Over 4 years of experience in in regulatory affairs. Languages: Ukrainian, Russian, English.
	Larisa Utyusheva Corrector Higher pedagogical education. Experience in the field of mass media for over 15 years. Work experience as a literary editor for over a year.
Legal department
	Glib Shcherbak Legal Counsel Master of law More than 8 years of experience in law, extensive experience in legal support of pharmaceutical companies. Fluent in Russian, Ukrainian and English.
Administrative department
	Andrii Trykisha cManager of Translation Department University degree in English and French languages, 10-year experience in medical translations, including CAT-tools, PM skills at the level of medical translation agency.
	Maryna Kholodnitska Manager of Translation Department University degree in Translation Studies, English and French languages.
	Elena Uchaeva Key Account Manager University degree in economics and international relations with knowledge of English and Japanese. Experience more than 6 years. The main responsibility in the company's activities is building of relationships with Customers and organizing the company's work.
	Olga Skalevska Office-manager University degree in Human Resources and Civil Service Documentation. Professional experience of more than 5 years. The main responsibility in company is organisation and support of daily activities.
	Andriy Bukalo Logistics specialist Higher education in the sphere of production. Experience in the field of logistics for more than 8 years.

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