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.
Degree in finances and economy, second degree in quality, certification and standardization. More than 18 years of experience in registration, safety and quality management of medicines and medical devices. More than 500 pages of publications on regulatory topics in specialized mass media. Fluency in English, excellent knowledge of the regulatory legislation of Ukraine, the CIS and the EU.
University degree in finance and economic. Experience in the field of administration more than 18 years. The main responsibility in the company’s activities is building of relationships with Customers and organizing the company’s work.
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.
Bachelor’s degree in Biotechnology and Bioengineering and Master’s degree in Biomedical Engineering. Second Master’s degree in Quality, Standardization and Certification. Over 4 years of experience in the field of medical device regulation.
Higher chemical-technological and chemical-pharmaceutical education, more than 25 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.
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 10 years in the registration of medicinal products.
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 10 years in the registration of medicinal products.
Higher education in the sphere of chemistry. Professional experience of more than 8 years of experience in a quality control laboratory and over 15 years of experience in registration of medicinal products.
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.
University degree in biotechnology, second degree in finance. PhD in biotechnology. Experience in scientific research and teaching for 10 years and more than 5 years of experience in registration of medicinal products. Scientific publications in international journals, participation in scientific conferences.
University degree in Biotechnology, over 9 years of experience in registration of medicinal products.
University degree in Pharmacy. 2 years in pharmaceutical distribution, more than 12 years in state registration of medicinal products.
University degree in biology, PhD in biology. Over 10 years of experience in a development and nonclinical study of medicinal products and over 15 years of experience in registration of medicines.
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 10 years.
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.
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.
Higher education in chemistry. Knowledge of the legislation of CIS countries and EAEU. Experience in state registration of pharmaceutical products for more than 6 years in Ukraine and CIS countries.
Higher chemical education. Work experience in the pharmaceutical industry is more than 15 years, including 8 years in the field of state registration of medicinal products. Knowledge of regulatory legislation of Ukraine, EU, EAEU and CIS countries. Scientific publications, development and support of the State Pharmacopoeia of Ukraine, participation in conferences and seminars.
Higher education in chemistry, specialty “Biochemistry”. Second higher education in the specialty “Management”, educational program “Quality, standardization and certification”. Experience in the state registration of pharmaceutical product for more than 8 years in the CIS region.
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.
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.
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.
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 10 years.
Higher education in medicine, speciality – medical affairs. Additional specialisation in Quality Control of medicinal products in the pharmaceutical industry. Work experience in a pharmaceutical company in the quality control department. Overall experience in the pharmaceutical industry for over 20 years. Knowledge of the legislation of Ukraine, CIS and EAEU countries.
M.Pharm., Ph.D. in Pharmaceutical Science, specialty – Pharmacology. Professional experience of more than 12 years, including over 7 years in pharmacovigilance. Knowledge of pharmacovigilance legislation of Ukraine, EU, EAEU and CIS countries. Scientific publications, participation in conferences.
Higher pharmaceutical education, specialty – pharmacy. Over 34 years of professional experience, including over 14 years in pharmacovigilance. Knowledge of legislation in the field of pharmacovigilance of Ukraine, EU, EAEU and CIS countries.
Higher education in the fields of biotechnology and bioengineering. Knowledge of regulatory requirements in the field of recognition / certification of the conformity of drug production with GMP requirements. With over 2 years of experience in chemical laboratory, experience in the field of recognition / certification of the conformity of drug production with GMP requirements is 3 years.
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.
Higher technical education in Biomedical Engineering. Conducting audits of domestic and foreign manufacturers. Writing and certification of quality management systems, production staging. Preparation of technical documentation for CE marking. Experience in regulatory affairs over 19 years, conducting registration procedures and conformity assessment of medical devices. Conducting thematic seminars.
University degree in “Biomedical engineering”. The author of scientific publications; participation in international scientific conferences. Experience in the regulatory sphere – more than 5 years. Conducting thematic seminars.
Master’s degree in “Medical equipment engineering”. Research articles, participation in international conferences. Experience in the regulatory sphere – more than 4 years.
Bachelor degree in Biomedical Engineering. Master degree in Metrology and Data Measurement Systems. Knowledge of regulatory legislation on medical devices. Experience in the regulatory sphere – more than 3 years.
University degree with knowledge of English and Japanese. Knowledge of regulatory legislation on medical devices. Experience – more than 6 years.
Master’s degree in ecology and environmental protection. Total work experience of 18 years of which 7 years in metrology and more than 5 years in the field of medical device regulation
Higher education in the specialty “Biotechnology”. Master’s degree in “Quality, standardization and certification”. Work experience in the laboratory in the direction of “microbiology” for more than 3 years. Experience in the regulatory sphere – more than 6 years.
University degree in Industrial biotechnology. Experience in the regulatory sphere – more than 10 years.
Higher pharmaceutical education in the specialty “Technology of pharmaceutical preparations”. Experience in pharmaceutical production for more than 10 years. Experience in the regulatory sphere – 1 year.
Higher technical education in the specialty “Chemical Technology”. Over 4 years of experience in chemical laboratory. Experience in the regulatory sphere is more than 2 years.
Higher technical education. Specialist in certification of domestic production. Experience in quality management systems for more than 10 years.
Higher technical education in the specialty “Biotechnology”. Knowledge of regulatory requirements in the field of cosmetic products, disinfectants, food, including food supplements, food intended for infants and young children, food for special medical purposes. Extensive work experience in the development of technical conditions, labeling and marketing of disinfectants, food and cosmetic products, as well as in the development and implementation of HACCP, GMP systems at food and cosmetic enterprises.
Higher technical education. Knowledge of regulatory requirements in the field of cosmetic products, disinfectants and food products.
University degree in medicine. Perfect knowledge of graphics software and printing technologies. Experience in printing industry – 23 years. Over 10 years of experience in regulatory affairs. Languages: Ukrainian, Russian, English.
Higher technical education. Outstanding knowledge of graphics software and printing technologies. Over 10 years of experience in printing industry. Over 5 years of experience in regulatory affairs. Languages: Ukrainian, Russian, English.
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.
Education in the sphere of production. Perfect knowledge of graphics software. Over 8 years of experience in design industry. Languages: Ukrainian, Russian, English.
Higher pedagogical education. Experience in the field of mass media for over 15 years. Work experience as a literary editor for over a year.
More than 8 years of experience in law, extensive experience in legal support of pharmaceutical companies. Fluent in Russian, Ukrainian and English.
Higher economic education.
University degree in Translation Studies, English and French languages.
University degree in Translation Studies, English and French languages.
University degree in Service sector with knowledge of English. Experience more than 5 years. The main direction in the company’s activity is support for cooperation with customers.