Health care regulation around the world is constantly evolving and is putting increasing emphasis on consumer safety. These changes are often very crucial. Orientation in legislation, individual processes and procedures and also in their time and economic context is not easy. In order to properly evaluate all the possibilities and impacts this area needs to be given the necessary attention.
Therefore, based on our many years of experience and with regard to the permanently increasing demands in the field of regulation of medicinal products, both human and veterinary, medical devices, food supplements and cosmetics, we have established a company whose main task is to constantly monitor the current legislative requirements and offer the most effective way of solution to request of the client. Our services include the entire life cycle of the product, from its development to its successful launch.
Our team of Regulatory Affairs and Pharmacovigilance Managers provide you with a competitive advantage to ensure your products are successfully registered and safely monitored all around EU.
Regulatory House offers regulatory and pharmacovigilance services primarily in the area of medicinal products, cosmetics, veterinary products, medical devices and food supplement.
Ing. Zuzana Grycová
CEO – Regulatory Affairs Director
Zuzana used to work as RA director in Archie Samuel since 2010 and as Archie Samuel and partners created in beginning 2014 the joint venture company Regulatory House Zuzana was appointed as CEO and RA Director. Zuzana has more than 20 years experiences in regulatory affairs – as she used to work at government authority - Institute for State Control of Veterinary Biologicals and Medicines and in the industry. Zuzana served as Head of regulatory affairs ad PhV department in Pliva-Lachema (oncology) and later on in Bioveta (veterinary) as regulatory affairs director and member of the management team of the company.
Zuzana Grycova holds Ing. from University of Chemical Technology, Pardubice.
Kateřina Nerušilová M.D.
Katerina in last years used to work as pharmacovigilance manager in Ingers Industrial Solutions s.r.o. and as Ingers Industrial Solutions and partners created in the beginning of 2014 joint venture company Regulatory House she was appointed as Pharmacovigilance Director.
Katerina has more than 20 years of extensive experiences in area of drug regulation as she used to work in university environment served as associate professor in department of pharmacology Masaryk University Brno, later on as clinical pharmacology and pharmacovigilance specialist in Pliva-Lachema and as well in the area of government services – State Institute for drug Control as evaluator specialist. Katerina Nerusilova holds M.D. from Masaryk University, Brno.
Jiří Deml M.D.
Jiri between years 2008 and 2012 used to work in area of medicines regulation as Deputy Director for Regulatory Affairs of the State Institute for Drug Control – Czech national competent authority and as member of Management Board of EMA - European Medicines Agency and as well as member of Management Board Telematics Committee of EMA.
In this positions he leverage more than 20 years of experiences within pharma industry – experience and achievements centre on his 12 years with Teva Pharmaceutical Industries and its European subsidiaries. During these years Jiri served as the Marketing & Sales Director for Central and Eastern Europe - building portfolio, regulatory and marketing strategies for the territory. Jiri started his carrier in Teva as CEO for Czech Republic and latter for Slovakia as well. Jiri currently serving as regulatory expert consultant of EATRIS-ERIC – supporting EATRIS Regulatory Knowledge and Support Centre and he is using his expertise in other EU project as PharmAround and Czecrin and co-operating with Department of Pharmacology of Masaryk University in Brno. Born in Czech Republic in 1967, Jiri Deml holds M.D. from the Masaryk University, Brno.
Mgr. Irena Babilonová
Regulatory Affairs Specialist
Irena has regulatory experience in the field of medical devices, cosmetic products and clinical trials. After finishing her studies she used to work at pharmacy and then moved to the regulatory area. Now she focuses on medical devices (CZ/EU legislation, classification, notification, reimbursement) and cosmetic products ( CZ/EU legislation, notification).
During her work at the faculty of Medicine in Brno she gained experience in clinical trials (preparation of documents for submission to Competent Authorities and Ethics Committees, GCP) and cooperating on international regulatory projects. Irena holds Master´s degree of pharmacy (University of Veterinary and Pharmaceutical Sciences, Brno) and she has done a part of the pharmaceutical internship in France. She is passionate about foreign languages (French, English, Portugese, Spanish).
Mgr. Edita Plevová
Edita started her carrier in our company as PhV officer and CT consultant in September 2017. After finishing her studies she used to work at veterinary medicine research, production and regulatory area.
During her work for veterinary pharma company she gained an experience in project management, clinical trials and also production area (GLP, GMP, GCP). She often cooperated with partners from foreign countries. Later on she moved specifically to regulatory area of dietary supplements and cosmetics. Edita holds Master´s degree from Univerzity of Palacky in Olomouc.
Mgr. Terézia Kuricová
Regulatory Affairs Manager
Terezia joined our team as Regulatory Affairs Manager in September 2017. Before starting her career in the regulatory area, she used to work at a pharmacy.
As a part of our regulatory team, she assists in all marketing authorization applications and also provides regulatory support throughout the product´s life cycle and development of pharmaceutical products. She is responsible for notification of Cosmetics and Medical Devices. Terezia holds Master´s degree of pharmacy (University of Veterinary and Pharmaceutical Sciences, Brno).
Ing. Zuzana Šmétková
Regulatory Affairs Specialist
Zuzana works as a RA specialist since 2010. After finishing her studies she used to work as administrative employee in State administration and then she moved to the regulatory area.
During her work for veterinary pharma company she gained experience in registration process of veterinary products (preparation and submission of documentation, communication with Competent Authorities). Now she focuses on Medical Devices, Cosmetics, Veterinary Products and assists in all areas of registration process of Medicinal Products. Zuzana holds Ing. from Brno University of Technology.
Ing. Ivana Maslonková
Regulatory Affairs /Quality Assurance Officer
Ivana works as a RA/QA officer and joined our team in July 2019. She is responsible for notification of Medical Devices and support regulatory team in whole registration process. Ivana graduated from Brno University of Technology – Faculty of Chemistry in 2018. During her studies, she have studied partly in Norway and also been in Japan as a intern for 3 months.
Martina Kyseláková M. D.
Pharmacovigilance Officer, EU QPPV deputy
Martina came to us after maternity leave and she has worked as a pharmacovigilance officer here since October 2018.
After finishing her studies Martina used to work at clinical genetics on faculty Hospital in Brno. Then she moved to pharmacovigilance area. She holds the M.D. from the Faculty of Medicine in Brno.