Bioanalytical Services in Coimbatore, India
Bioanalysis is essential at all stages of product development, and our bioanalytical services are integrated with our clinical capabilities. We are dedicated to delivering accurate, reliable, and streamlined bioanalytical services for complex programs, from method development to clinical sample analysis, empowering you to make informed research decisions.
Techniques and Technology Platforms
We also support pharmacokinetics (PK), toxicokinetics (TK), pharmacology, Bioequivalence, and Bioavailability Studies, along with biomarker assays from early discovery and preclinical bioanalysis to clinical and post-marketing studies. Bioanalysis is unique in its necessity for evaluating a therapeutic throughout the entire drug development cycle, ensuring comprehensive assessment and regulatory compliance.
BioAnalytical Method Development
SpinoS CRO has extensive experience and the capability to develop novel methods for quantifying small and large molecule compounds in various matrices. Optimal methodology is defined by the following key features:
Bio Method Validation
☆ All of our validated analytical methods comply with US FDA and EMA guidance for bioanalytical method validation, ensuring regulatory compliance and data integrity in our studies.
☆ We have over a hundred validated analytical methods available for immediate use, ensuring efficient and reliable results for your bioanalytical needs.
☆ We can seamlessly transfer your method to our laboratory and revalidate it for use at our site, ensuring compliance and reliability.
☆ We are continuously optimizing existing methods to ensure compliance with evolving regulatory requirements, maintaining high standards in our bioanalytical services.
Spinos Life Science - Top CRO Full Services in India
SpinoS was established to create a comprehensive Clinical Research Organization (CRO), offering end-to-end services for Phase studies while ensuring systems and processes comply with global regulatory standards..
Services
SpinoS offers GLP-compliant chromatographic assays and ligand-binding assays in our bioanalytical laboratory, utilizing LC/MS-MS technologies, including API 4000, API 5500, and Shimadzu 8045, along with advanced ELISA detection techniques. We provide comprehensive services, including method development, transfer, validation, and analysis of preclinical and clinical biological samples.
Sample Analysis
Bioanalytical Reporting
☆ We specialize in the preparation and issuance of high-quality bioanalytical reports that comply with company SOPs, current regulatory guidelines, and client specifications, ensuring accuracy and reliability in all deliverables.
☆ We have developed high-quality, regulatory-compliant templates for sample analysis and method validation reports, significantly reducing report compilation turnaround time and enhancing efficiency in our bioanalytical processes.
