We are Fumoprep
Flexible CRO partner and smart solutions
for your unique challenges.
Reliability in a regulated 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 OGYEI, last inspection in February 2020). 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. Your awareness of what you’re paying for is a key part of our business as well as the responsibility for the results we release.
History
2006 | – | Establisment in Mórahalom, Hungary |
2009 | – | GMP certification |
2013 | – | Starting new operation in Budapest, Hungary |
2013 | – | ISO 9001 inspection |
2013 | – | GMP inspection |
2014 | – | GLP inspection – Certified test site/facility |
2017 | – | GLP inspection |
2020 | – | GLP inspection |
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;
- See detailed services (link to services);
- Have a question? Contact us.
Instruments
- Agilent Ultivo triple quadrupole LC/MS (LC/TQ)
- Agilent 8860 GC-FID
- Dionex Ultima 3000 UHPC
- JASCO V-730, UV-VIS spectrophotometer
- VIAVI MicroNIR
- RAMAN
Management Team
János Elek, Ph.D. Scientific Director
János Elek has been a praticing analyst for more than 20 years with a PhD in chemistry. He has also worked as a laboratory analyst, university lecturer and industrial consultant. Since 2013 he has been supporting the operational management of FumoPrep with the coordiantion of the scienctific activities and business development.
János Török, Ph.D. General Manager
János Török started his analytical career more than 20 years ago at the University of Debrecen. During his Ph.D. studies he became familiar with the chromatography, spectroscopy and the hyphenated techniques especially the HPLC-MS/MS methods.
After 9 years, he moved from the academic field to the biotech R&D industry and experienced the high throughput screening methods and lab automation.
Since 2013 he has been the general manager of FumoPrep Ltd. and study director of 200+ GLP studies.
Angéla Simon, M.Sc. Head of Quality Assurance
Angela Simon has 7 years experience in Quality Assuarance of GLP. She started her career at Teva Pharmaceuticals as an R&D Research Analyst and she conducted API method development, validation and routine analysis.
Angela then continued her carrier as an Analytical Groupleader at R&D managing and supporting analysts in the chromatography of active pharmaceutical ingredients.
After 6 years she decided to move to the analysis of sterile phamaceutical products still within Teva.
In 2013 she joined our company and, under her supervision, FumoPrep was well-prepared for the first GLP inspection.
As of 2020 we have been certified by the Autorithy for the third time in a row.
Angela is committed to people and system development.