B‘SYS is organized as GLP (Good Laboratory Practice) test facility and is since 2004 thus reliably provides ion channel services in compliance with GLP principles for regulatory submission of compliant data. All GLP studies are supported by method validation procedures providing solid evidence of method suitability for regulatory purposes.
B‘SYS operates via independent QAU (Quality Assurance Unit) for inspection of GLP studies. Study related GLP records are stored in the GLP archive along with training, calibration, and maintenance record sheets. Hallmark of GLP studies are the defined study accomplishment and precise execution.
- Generation of compliant data for regulatory submission according to ICH S7A/S7B Guideline
- B‘SYS is a certified Swiss GLP test facility Swiss GLP Test Facilities
- Archiving of GLP records for 10 / 15 years
- GLP certificate
GLP (Good Laboratory Practice) serves as quality management system concerning the organizational conditions under which non-clinical safety studies are accomplished. The test results generated in accordance with GLP principles in an OECD member country.
GLP validated patch clamp assays
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Assay design and appplication schemes can be adapted to your needs.
Available options for GLP-assays:
- Full glass equipment
- Temperature control (RT or physiological temperature)
- Dose formulation analysis (GLP or non-GLP)
For more details or offers, please contact us: [email protected]