We are Fumoprep
Flexible CRO partner
Unique solutions
GLP environment
What We Do
FumoPrep is an analytical contract research organization (CRO) based in Budapest, Hungary. Our company provides analytical services, mainly to toxicological research companies and the pharma industry.
We have been a certified GLP test site since 2014 (inspected by National Institute of Pharmacy and Nutrition, last inspection in June 2023). Our maximum flexibility and responsiveness are the key to your success.
Why FumoPrep
FumoPrep is committed to your success. We conduct our tests in a strictly regulated environment. Our Clients often get lost in data tables and scientific reports. We believe in the power of comprehensible interpretations. The three key principles driving our business are: transparency, reliability and providing outstanding value for your money.
History
- 2006 – Establisment in Mórahalom, Hungary
- 2009 – GMP certification (human)
- 2013 – Establishment new operation in Budapest, Hungary
- 2013 – ISO 9001 inspection
- 2013 – GMP certification (human)
- 2014 – GLP inspection – Certified test site/facility
- 2017 – GLP inspection
- 2020 – GLP inspection
- 2023 – GLP inspection
-
2024 – GMP inspection (veterinary)
| 2006 | – | Establisment in Mórahalom, Hungary |
| 2009 | – | GMP certification (human) |
| 2013 | – | Starting new operation in Budapest, Hungary |
| 2013 | – | ISO 9001 inspection |
| 2013 | – | GMP certification (human) |
| 2014 | – | GLP inspection – Certified test site/facility |
| 2017 | – | GLP inspection |
| 2020 | – | GLP inspection |
| 2023 | – | GLP inspection |
| 2024 | – | GMP inspection (veterinary) |
Services
- Analytical method development and validation in the field of non-clinical dose formulations and bioanalysis.
- Development of custom methods for UVCB materials.
- Consultancy in the filed of analytical chemistry and quality assurance.
- Method development for R&D, production and QC purposes.
- Physico-chemical testing for manufacturing of veterinary medicinal products under EU-GMP
- Contract release and batch certification of veterinary medicinal products (import included) under EU-GMP
- Advisory activity on different scientific fields
- Have a question? Contact us.
Instruments
- Agilent Ultivo triple quadrupole LC/MS (LC/TQ)
- Agilent 8860 GC-FID
- Dionex Ultima 3000 UHPC
- XRF Analyser Pro XEP04 Spectroscout
- Dissolution Test Station Hanson SR8-Plus Hanson
Management Team
Béla Gyetvai, Ph.D. hon. assoc. prof. Executive Director
Béla Gyetvai originally graduated as veterinarian and microbiologist at the University for Veterinary Sciences Budapest.
He had been working as head of laboratory of a food, feed and veterinary clinical microbiological state laboratory for more than 12 years before he were assigned to be leader of the Central Laboratory of the National Food Investigation Institute.
After 5 years, at the National Food Investigation Institute, he joint one of the domestic market leader animal health company as leader of research, development and registration work.
After having spent 12 years there he jont Fumoprep as leader of the quality assurence unit in 2021.
He has 25 year experience in laboratory accreditation and 12 year in GMP.
He has been teaching as honorary associate professor at the Semmelweis University in Budapest and the University of Veterinary Medicine in Budapest
Mária Kriston, M.Sc. Head of Quality Assurance
Mária Kriston originally graduated as food industry engineer University of Horticulture and Food Industry Budapest and quality-management engineer at the University of Technology and Economics Budapest.
She had been working in Pharmaceutical Control and Development Laboratory 12 years, as head of microbiological laboratory, QA and head of Validation group.
She had 6 years practice at pharmaceutical manufacturing as QA and QP.
She worked as expert BSL 3 and BSL 4 laboratory construction at National Public Health Center and another project for BSL 4 mobile laboratory (TGYDGL09). Experienced 7-9 project for clean room design, construction, validation, qualification for pharmaceutical and medical device manufacturers.
She joint Fumoprep as leader of the quality assurance unit in 2022.
He has 11 years’ experience in Medical Device notification, 4 years in GLP and more 20 years in GMP.