Bioanalytical Services

Bioanalytical Services in Coimbatore

Bioanalysis is critical at all stages of product development. Bioanalytical services are intertwined with our clinical capabilities. We are committed to providing accurate, reliable, and streamlined bioanalytical services for the most difficult programmes, from method development to clinical sample analysis, to help you make confident research decisions.

  • Chromatography
  • Mass spectrometry
  • Immunochemistry
  • Cell-based assays
  • Flow cytometry
  • Molecular biology
Bioanalytical Services

Techniques and Technology Platforms

We also support PK/TK, Pharmacology, Bioequivalence, and Bioavailability Studies, as well as biomarker assays from early discovery and preclinical bioanalysis to clinical and post marketing studies. Bioanalysis is somewhat unique in that it is required for the evaluation of a therapeutic throughout the entire drug development cycle.

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BioAnalytical Method Development

SpinoS CRO 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:

  • Sensitivity
  • Reproducibility
  • Efficiency
  • Transferability

Bio 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 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.

Spinos Life Science and Research Private Limited

SpinoS was established with an aim to build a full-fledge CRO offering end to end service with respect the phase studies, with system and process in compliance with global regulatory standards.

Services

SpinoS offers GLP-compliant chromatographic assay and ligand-binding assay in our bioanalytical laboratory using LC/MS-MS Which includes API 4000, API 5500, Schimadzu 8045 and ELISA with state-of-the-art detection techniques. SpinoS provides method development, transfer, validation, and analysis of preclinical and clinical biological samples.

Sample Analysis

  • 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.
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Bioanalytical Reporting

☆  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.

LIST OF VALIDATED METHODS

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