Контактная информация

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

Advisor

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.

 2

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.

 3

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.

 4

Nataliya Kotovska

Head of FMCG department

Higher education in biotechnology. Professional experience in the regulatory affairs -  3 years. Knowledge of the regulatory legislation of Ukraine and the EU in the field of registration of special food and cosmetic products. The author of scientific publications in an international editions, participation in scientific conferences.

 5

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

 6

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.

 7

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.

 8

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.

 9

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.

 10

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.

 11

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.

 12

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.

 13

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.

Department of International registration of products

 14

Svetlana Barmakova

Head of International Regulatory Affairs Department

University degree in biotechnology, second degree in psychology. Working experience in drug regulatory affairs in CIS region is more than 10 years; experience of management and organization of regulatory processes is more than 5 years.

 15

Liudmyla Shumliak

International Regulatory Affairs manager

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.

 16

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.

 17

Margaryta Mishyna

International Regulatory Affairs manager

University degree in Pharmacy. Timely upgrading of qualification. Working experience in drug regulatory affairs in Ukraine and CIS region is 8 years Sufficient qualification and knowledge of international and Ukraine's legislation in registration of medicinal products.

Medical affairs department

 18

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.

 19

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.

 20

Olga Efimova

Medical expert-editor

University degree in medicine. The second University degree in art and design. Experience in medical practice. Excellent knowledge of professional English.

 21

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.

Pharmacovigilance Depertment

 22

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.

 23

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.

 24

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.

Department of product quality management, standardization and certification of production

 25

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.

 26

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.

Medical devices certification and conformity assessment department

 27

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.

 28

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.

 29

Maxym Shatayev

Specialist of Certification and Conformity Assessment

University degree in automation and computer systems. Over 7 years of experience in regulatory issues. Knowledge of regulatory legislation of Ukraine and the EU.

 30

Olga Kavun

Specialist on standardization, certification and quality

University degree in “Company economics”. Professional experience in manufacturing in the sphere of development and support of QMS regarding the manufacture of medical products of more than 4 years. Successful certification and revision audits by domestic and international conformity assessment bodies. Successful completion of audits on the part of customers of a company. Professional experience in the field of conformity assessment of medical products of more than two years.

 31

Oksana Yevlakhovych

Junior specialist of Certification and Conformity Assessment Department

University degree in chemistry and technology. The author of scientific publications; participation in international scientific conferences.

 32

Anna Hnatiuk

Specialist of Certification and Conformity Assessment

University degree in "Biomedical engineering".  The author of scientific publications; participation in international scientific conferences.

FMCG

 33

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.

 34

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

 35

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.

 36

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.

 37

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.

Legal department

 38

Yulia Dovgopola

Lawyer

Master`s degree in Law. Specializes in corporate and civil laws. Experience in the legal field is over 3 years. Takes part in specialized events. Membership of the UBA. Languages: Ukrainian, Russian, English.

Administrative department

 39

Andrii Trykisha

Manager 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.

 40

Kateryna Bazylevska

Head of Translation Department

Bachelor’s degree in International Relations, Specialist of International Law. Professional qualification – Lawyer, Translator. Work experience in capacity of translator for more than three years. Member of international seminars and conferences, science writer in the field of international economics.

 41

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.

 42

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.

 43

Andriy Bukalo

Logistics specialist

Higher education in the sphere of production. Experience in the field of logistics for more than 8 years.

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