SpinoS offers GLP-compliant chromatographic assay and ligand-binding assay in our bioanalytical laboratory using 4 LC/MS-MS Which includes API 4000 and API 5500 and ELISA with state-of-the-art detection techniques. SpinoS provides method development, transfer, validation, and analysis of preclinical and clinical biological samples.
Analytical Method Development
SpinoS has broad-spectrum experience and capability to develop novel methods to quantify small and large molecule compounds in various matrixes.
Optimal methodology is considered as defined by the follow features:
Analytical Method Validation
- All of our validated analytical methods meet the US FDA and/or EMA guidance for bioanalytical method validation.
- Over a hundred validated analytical methods ready for use.
- We offer superior sensitivity and reproducibility for complex analytes.
- We can transfer your method to our laboratory and revalidate for use at our site.
- We are continually optimizing existing methods to comply with ever-changing regulatory requirements.
- Specialize in the analysis of biological samples for pre-clinical and clinical drug trials.
- Offer scientific expertise in performing BA/BE studies following costs and timelines that suit our client’s needs.
- Analytical test is conducted in compliance with customizable quality stand.
- Specialized in the preparation and issuance of high quality bio analytical reports in compliance with company SOPs, current and appropriate regulatory guidelines and/or client specifications.
We have developed the high quality and regulatory compliant of sample analysis and method validation report template which dramatically decreases report compilation turnaround time.