Our team

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. 17 years of experience in the Laboratory of Neurochemistry and Spectrophotometric Analysis. 20 years of 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 – 20 years. Author of a number of scientific articles; regular active participation in specialized seminars, trainings. Knowledge of the regulatory legislation of Ukraine and the EU. Interaction with regulatory authorities and expert organizations in Ukraine.

Over 7 years of experience in medical device regulation. A Bachelor’s degree in Biotechnology and Bioengineering and two Master’s degrees — in Biomedical Engineering and in Quality, Standardization and Certification.

Higher education in biology (specializing in virology) and over 15 years of professional experience in the field.
In-depth knowledge of the regulatory legislation of CIS countries and the Eurasian Economic Union (EAEU) regarding the registration of medicinal products, medical devices, specialized food products, and cosmetics. Over 13 years of practical experience in managing registration procedures for medical products in CIS countries, including working with national regulatory requirements and the specifics of registration processes in various jurisdictions.

 University degree in Pharmacy and in chemical technologies. Over 14 years of experience in the field of registration of medicines and medical devices in the CIS countries, Africa and the EU.

Knowledge of regulatory legislation regarding medical devices, medicines in Ukraine, the CIS region, the EU, MENA.
Overall experience in the regulatory field – more than 15 years.

Высшее образование в области химии. Более 10 лет опыта в сфере государственной регистрации фармацевтической продукции в Украине и странах СНГ. Глубокое знание законодательства и регуляторных требований стран СНГ и ЕАЭС.

Higher chemical education. Work experience in the pharmaceutical industry is more than 20 years, including 11 years in the field of state registration of medicinal products. Knowledge of regulatory legislation of Ukraine, EU, EAEU and CIS countries. Scientific publications, development of monographs of the State Pharmacopoeia of Ukraine, participation in conferences and seminars.

Holds a higher education degree in Industrial Biotechnology, with the qualification of Specialist in Industrial Biotechnology. Possesses over 18 years of experience in regulatory affairs and the state registration of medicinal products in international markets, specifically within the CIS and EAEU countries. Has practical experience in managing the registration of medicinal products, implementing variations to registration dossiers, and interacting with regulatory authorities in compliance with national legislation and EAEU regulatory requirements.

Higher education in Biotechnology, Technology of Biochemical Pharmaceuticals, and Engineering. 2 years of experience in technology development and synthesis of anticancer drugs as well as over 20 years of practical experience in the registration of pharmaceuticals, medical devices, and cosmetic products. Comprehensive knowledge of the regulatory framework for drug registration in Ukraine, EU, EAEU, and CIS countries.

Higher education in chemistry, specialty “Biochemistry”. Second higher education in the specialty “Management”, educational program “Quality, standardization and certification”. Over 11 years of experience in Regulatory Affairs (RA) and marketing authorization of medicinal products across international markets, including the CIS region. Possess deep knowledge and practical expertise in applying relevant legislation and regulatory requirements of the CIS and EAEU countries.

M.Pharm., specialization in Pharmacovigilance. Ph.D. in Pharmaceutical Science, specialty – Pharmacology. Professional experience of more than 14 years, including over 10 years in pharmacovigilance. Knowledge of pharmacovigilance legislation of Ukraine, EU, EAEU and CIS countries. Scientific publications, participation in conferences.

Higher pharmaceutical education, specialising in Pharmacy. Over 37 years of professional experience in the pharmaceutical field, including more than 20 years in pharmacovigilance.
Extensive practical experience in organising and maintaining pharmacovigilance systems, monitoring the safety of medicinal products, preparing pharmacovigilance documentation, and interacting with regulatory authorities.
Specialisation in ensuring compliance of pharmacovigilance processes with national and international regulatory requirements, implementing Good Pharmacovigilance Practices (GVP), and maintaining the effective functioning of pharmacovigilance quality management systems.

Higher medical education, specialization in Obstetrics and Gynecology. Over 25 years of professional experience in the field. Over 11 years of experience in pharmacovigilance. Knowledge of pharmacovigilance legislation in Ukraine, the EU, the EAEU, and the CIS countries.

Higher pharmaceutical education, speciality – pharmacy. Over 23 years of professional experience, including more than 2 years in pharmacovigilance. Еxperience in inspections of pharmacies, medical institutions and pharmaceutical warehouses. Knowledge of the pharmacovigilance legislation of Ukraine, the EU, the EAEU and the CIS countries. Рractical experience in organising and maintaining pharmacovigilance systems, monitoring the safety of medicinal products, preparing pharmacovigilance documentation, and interacting with regulatory authorities.

Higher education in the field of veterinary medicine. Professional experience in the field of pharmacovigilance 9 years. Knowledge of pharmacovigilance legislation of Ukraine, EU, EAEU and CIS countries.

Higher pharmaceutical education, specialty — Pharmacy, qualification — Pharmacist. More than 16 years of professional experience in the pharmaceutical field, including over 8 years of experience in pharmacovigilance. Author of scientific publications and participant in professional conferences. Knowledge of pharmacovigilance legislation and regulatory requirements in Ukraine, the EU, the EAEU, and CIS countries.

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. Knowledge of the regulatory legislation of Ukraine, and the EU.Performing the duties of the company’s quality manager and overseeing supplier audits.

Master’s degree in “Medical equipment engineering”. Research articles, participation in international conferences. Knowledge of the regulatory legislation for medical devices of Ukraine and EU. Experience in developing the technical documentation for medical devices for the domestic manufacturers. Experience in the regulatory sphere – more than 7 years.

Bachelor degree in Biomedical Engineering. Master degree in Metrology and Information-measuring Technology. Knowledge of regulatory legislation on medical devices. Experience in the regulatory sphere – more than 6 years.

Higher technical education in the specialty “Chemical Technology”. Knowledge of the regulatory legislation for medical devices of Ukraine and EU. Over 4 years of experience in chemical laboratory. Experience in the regulatory sphere is more than 6 years.

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 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 – more than 3 years.

Versatile experience in the regulatory field – more than 15 years.
Full regulatory support of conformity assessment procedures, analysis and preparation of registration dossiers, instructions and labeling, development and preparation of technical documentation for domestic manufacturers, interaction with conformity assessment bodies and market surveillance authorities.

Higher technical education in “Biomedical engineering”. Experience in the manufacturing of cardiac implants is 2 years. Experience in the regulatory field of medical devices is approximately 3 years of experience.
Development and preparation of technical documentation for domestic manufacturers; support of the conformity assessment procedure at all stages of documentation preparation in accordance with regulatory requirements; and preparation and submission of notifications to relevant authorities on behalf of the manufacturer.

Higher technical education in the specialty “Chemical Technology”. Over 2 years of experience in a chemical laboratory. Experience as a process engineer for 14 years, experience as a standardization engineer for 6 years.

Higher technical education in Biotechnology and Bioengineering. Experience in the production of diagnostic kits for enzyme-linked immunosorbent assay (ELISA) – 5 years. Experience as a manager-methodologist in chemiluminescent immunoassay (CLIA) – 1 year. Experience in the regulatory field is more than 1,5 year.

Higher economic education. Practical experience working with technical documentation for the registration of medical devices. Knowledge of regulatory legislation on medical devices. Experience in tender procurement and in the regulatory field is 3 years.

Higher biological education. Work experience in a plant in vitro cultivation laboratory — 2 years. Experience as a biotechnologist in the field of eco-innovation — 2 years. Regulatory affairs experience less than 1 year.

Higher technical education. Outstanding knowledge of graphics software and printing technologies. Over 10 years of experience in printing industry. Over 10 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 10 years of experience in in regulatory affairs. Languages: Ukrainian, Russian, English.

Educational background in Production Management. Perfect knowledge of graphics software.
Over 10 years of experience in design industry. Over 5 years of experience working with medical product packaging and labeling, including ensuring compliance with regulatory requirements. 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. Over 9 years of experience in proofreading medical and pharmaceutical documentation.

 Higher economic education.

University degree in Translation Studies, English and French languages.

Higher Degree in Philology.
Specialization: English Philology and Translation, Two West European Languages.

University degree in Service sector with knowledge of English. Experience more than 6 years. The main direction in the company’s activity is support for cooperation with customers.

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.