Services
Chromatographic and spectroscopic methods
Validation
We can develop and validate analytical methods for single and multicomponent (even UVCB) test items from a wide range of concentration and matrices. The studies run in accordance with the relevant GLP regulations.
If you need any special reqiurements (FDA, OECD, CIPAC, ICH or others), please contact us.
Testing of Chemicals
The following tests are available in our facility:
- OECD 101 – UV-VIS Absorption Spectra
- OECD 105 – Water Solubility (shake flask or microcolumn method)
- OECD 107 – Partition coefficient (SF method)
- OECD 111 – Hydrolysis as a Function of pH
- OECD 117 – Partition coefficient (HPLC method)
- OECD 121 – Adsorption coefficient (HPLC method)
- OECD 123 – Partition coefficient (Slow stir method)
Other test requested? Contact us with your special needs.
The following tests are available in our facility:
| OECD 101 | – | UV-VIS Absorption Spectra |
| OECD 105 | – | Water Solubility (shake flask or microcolumn method) |
| OECD 107 | – | Partition coefficient (SF method) |
| OECD 111 | – | Hydrolysis as a Function of pH |
| OECD 117 | – | Partition coefficient (HPLC method) |
| OECD 121 | – | Adsorption coefficient (HPLC method) |
| OECD 123 | – | Partition coefficient (Slow stir method) |
Other test requested? Contact us with your special needs.
Ecotox Analysis
- Supporting the analyisis of aquatic studies (OECD 201, 202, 203, etc…);
- Stability measurement of the test item under ecotox-test conditions.
Formulation Analysis
- Supporting the analysis of oral or dietary studies;
- Determination of test item concentration in gavage formulations and diets;
- Preparation of gavage formulations;
- Stability test of gavage formulations and diets.
Veterinary examinations (Bioequivalence, Pharmacokinetics, Target Animal Safety, etc.):
The following tests are available in our facility:
- Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances – (EMEA/CVMP/627/01)
- Pharmacokinetic studies in target animal species – (EMEA/CVMP/EWP/133)
- Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances (dose determination/dose confirmation) – (EMEA/CVMP/627/01)
- Target Anmal Safety Study – (VICH GL43)
- In vivo bioequivalence studies for veterinary medicinal products – (EMA/CVMP/016, VICH GL52)
- In vivo bioequivalence studies for veterinary medicinal products – (EMA/CVMP/016, VICH GL52)
- Studies to evaluate the metabolism and residue kinetics of veterinary drugs in foodproducing animals: marker residue depletion studies to establish product withdrawal periods – (VICH GL48)
- User safety of topically administered veterinary medicinal products – (EMA/CVMP/SWP/721059)
Other test requested? Contact us with your special needs.
Veterinary examinations (Bioequivalence, Pharmacokinetics, Target Animal Safety, etc.):
The following tests are available in our facility:
- Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances – (EMEA/CVMP/627/01)
- Pharmacokinetic studies in target animal species – (EMEA/CVMP/EWP/133)
- Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances (dose determination/dose confirmation) – (EMEA/CVMP/627/01)
- Target Anmal Safety Study – (VICH GL43)
- In vivo bioequivalence studies for veterinary medicinal products – (EMA/CVMP/016, VICH GL52)
- In vivo bioequivalence studies for veterinary medicinal products – (EMA/CVMP/016, VICH GL52)
- Studies to evaluate the metabolism and residue kinetics of veterinary drugs in foodproducing animals: marker residue depletion studies to establish product withdrawal periods – (VICH GL48)
- User safety of topically administered veterinary medicinal products – (EMA/CVMP/SWP/721059)
Other test requested? Contact us with your special needs.
Advisory Activity
Quality system related affairs
- Accreditation of testing laboratories (ISO EN 17025)
- GMP
- GLP
- HACCP
- MDR (Medical Devices Regulation)
- IVDR (In vitro Diagnostic Medical Devices Regulation)
- Clean room technology consultancy
- Consultancy BSL 3 and BSL 4 laboratory construction, validation, qualification
Other affairs
- Food, feed, veterinary clinical microbiology
- Conducting veterinary clinical trials
- Planning cleanrooms
- Establishment of GMP plans
- Development of veterinary medicinal products
- Registration of veterinary medicinal products in EU
- Pharmaceutical microbiology
R&D
FumoPrep can provide tailored analytical methods for your R&D projects in various fields of chemistry, such as purification, formulation, product and process development. In cooperation with our specialized partner Science Port Ltd. a very broad range of equipment and our experienced and enthusiast team are at your disposal to support you in your R&D challenges.
If you need an experienced analytical team in your R&D project, do not hesitate to contact us.
Bioanalysis
Determination of the test item and/or metabolites from body liquids and tissues.
Validation of the method according to the FDA guidelines.
R&D
FumoPrep can provide tailored analytical methods for your R&D projects in various fields of chemistry, such as purification, formulation, product and process development. In cooperation with our specialized partner Science Port Ltd. a very broad range of equipment and our experienced and enthusiast team are at your disposal to support you in your R&D challenges.
If you need an experienced analytical team in your R&D project, do not hesitate to contact us.
Bioanalysis
Determination of the test item and/or metabolites from body liquids and tissues.
Validation of the method according to the FDA guidelines.
Contact Us
Questions and request are welcome
Call us — +36 30 994 7413