Сonsultation

Our team

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

Each of them is an expert in their field and constantly improves their knowledge and skills. Our team is growing rapidly and is replenished with both full-time and freelance specialists. We all care about the project, love the client and are focused on the result.

Key Account Managers

Managing partner

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.

Irina Burtseva
Executive manager

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.

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.

Viktoriia Moroz
Key Account Manager

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.

Department of Registration of Medicines

Natalia Kinduris
Deputy Director

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.

Marina Kozlova
Head of the drug registration department

Higher chemical and technological education and pharmaceutical, more than 11 years of work experience in a control and analytical laboratory and more than 25 years of work experience in drug registration. Manages and coordinates the work of the back office.

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 10 years in the registration of medicinal products.

Tetiana Kuznetsova
Regulatory Affairs Specialist

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.

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.
 

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 and more than 5 years of experience in registration of medicinal products. Scientific publications in international journals, participation in scientific conferences.

Nataliia Lipisiienko
Regulatory Affairs Specialist

University degree in Biotechnology, over 9 years of experience in registration of medicinal products.

Oleh Kokovskyi
Manager of Regulatory Affairs

University degree in Pharmacy. 2 years in pharmaceutical distribution, more than 12 years in state registration of medicinal products.

Maryna Filonenko
Regulatory Affairs Specialist

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.

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 10 years.

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.

Elvira Kulyk
Regulatory Affairs Specialist CIS region

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.

Yuliia Komarova
Regulatory Affairs Specialist CIS region

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.

Iryna Bykova
Regulatory Affairs Specialist CIS region

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.

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 10 years.

Pharmacovigilance Depertment

Olena Shapka
Pharmacovigilance specialist

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.

Lidiia Bulyha
Pharmacovigilance specialist

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.

Liubov Ivanivna Nikitchenkova
Specialist in pharmacovigilance

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.

Department of product quality management, standardization and certification of production

Anastasiia Koval
Deputy head of Quality Department

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.

Tetiana Lupynis
Certification GMDP manager

Higher chemical education in the speciality “Chemistry of high-molecular compounds”. Work experience: more than 14 years in the manufacturing of medicines, 10 years in the regulatory sphere (certification of medicines manufacturing). Knowledge of regulatory legislation of Ukraine, EU countries and partner countries (USA, Canada, Switzerland, UK). Experience in inspection of enterprises manufacturing medicines.

Medical devices certification and conformity assessment department

Alla Somyk
Head of conformity assessment department

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.

Аnna Hnatiuk
AR Manager

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.

Daria Kustovska
Lead certification and conformity assessment specialist

Master’s degree in “Medical equipment engineering”. Research articles, participation in international conferences. Experience in the regulatory sphere – more than 4 years.

Oleksandra Fech
Certification and conformity assessment specialist

 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.

Olena Uchaieva
Certification and conformity assessment specialist

University degree with knowledge of English and Japanese. Knowledge of regulatory legislation on medical devices. Experience – more than 6 years.

Tetiana Prozorova
Certification and conformity assessment specialist

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

Alina Ermak
Certification and conformity assessment specialist

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.

Olga Pokas
Certification and conformity assessment specialist

University degree in Industrial biotechnology. Experience in the regulatory sphere – more than 10 years.

Mariia Bazhan
Certification and conformity assessment specialist

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.

Svitlana Kavetska
Certification and conformity assessment specialist

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.

Olha Romaniuk
Certification and conformity assessment specialist

Higher technical education. Specialist in certification of domestic production. Experience in quality management systems for more than 10 years.

FMCG

Oksana Oliynichuk
Head of FMCG department

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.

Olesia Bezushko
Specialist of FMCG department.

Higher technical education. Knowledge of regulatory requirements in the field of cosmetic products, disinfectants and food products.

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 – 23 years. Over 10 years of experience in regulatory affairs. Languages: Ukrainian, Russian, English.

Aleksey Suslin
Lead designer

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.

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.

Oleg Zhydchenko
Designer

Education in the sphere of production. Perfect knowledge of graphics software. Over 8 years of experience in design industry. 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

Maksym Lovkin
Legal advisor

He has a higher legal education and possesses 17 years of experience in the legal field, providing consultations on various legal matters related to business activities in Ukraine, including registration, certification, market approval, and advertising of pharmaceuticals and medical devices.

Administrative department

Svitlana Yevtushenko
Administrative Assistant

 Higher economic education.

Maryna Kholodnitska
Manager of Translation Department

University degree in Translation Studies, English and French languages.

Alina Subotina
Manager of Translation Department

University degree in Translation Studies, English and French languages.

Valeriia Dovbysh
Account manager

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.

We professionally perform registration of medicines, conformity assessment of medical devices, certification of cosmetics, disinfectants and special food products in Ukraine.
Our partners, international corporations and national manufacturers can best tell about our expertise and quality of work. For more than 15 years of work we have performed works for:

  • more than 150 manufacturers of medicines and active substances,
  • more than 800 manufacturers of medical devices and equipment,
  • more than 300 manufacturers of special food products and cosmetics.
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