SpinoS has been devoting itself to promote ICH-quality clinical trial for multinational pharmaceutical industries.
In order to advance the services for more comprehensive scopes in drug development, SpinoS established its bioanalytical laboratory with a new era of the company as a total solution provider from IND Phase I ~ III to post- marketing IV and BA/BE study.
SpinoS Bioanalytical Laboratory is a contract laboratory and specializes in providing high quality and speedy bioanalytial services for streamlining the entire drug development. Not only the Lab analytical competencies are continuing promoted for efficiency and technical capability, but also the management system of the Lab is constantly insisted to be in compliance with international standards.
SpinoS Lab bears the heritage of professional and service quality as part of SpinoS family, combining the advantage of decades of clinical experience and state-of-the-art analytical lab setup. It is now unique for pharmaceutical industries’ benefits in terms of all bioanalytical needs form the aspects of quality, efficiency and cost effectiveness.
SpinoS lab is your best partner in bioanalytical service. Each and every project undertaken by our experienced and highly trained team is customized to your individual needs. Our team is easily accessible for progress communication throughout all phases of a project from sample receipt to issuance of the final report.
SpinoS offers GLP-compliant chromatographic assay and ligand-binding assay in our bioanalytical laboratory using LC/MS-MS 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 bioanalytical 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.