Bioanalytical Services

Bioanalytical Services in India

In India, bioanalytical services encompass a diverse array of scientific and analytical offerings furnished by laboratories and research institutions to support the pharmaceutical and biotechnology sectors, along with academic and clinical research endeavors. These indispensable services facilitate the quantification and scrutiny of drugs, metabolites, biomarkers, and other biologically active substances across a spectrum of biological samples. They assume a pivotal role in processes such as drug development, pharmacokinetics, toxicology, and clinical research. Below are outlined some of the fundamental components of bioanalytical services that Vipragen is poised to provide:

  1. » Pharmacokinetic (PK) Studies

  2. » Bioequivalence Studies

  3. » Toxicokinetics (TK) Studies

  4. » Method Development and Validation

  5. » Clinical Sample Analysis

  6. » Mass Spectrometry and Liquid Chromatography

  7. » Regulatory Compliance: ICH M10 on bioanalytical method validation - Scientific guideline to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples.

  8. » Customized Services to meet the specific needs of clients, including method development, validation, sample analysis, and reporting.

  9. » Research and Development including the development of new analytical methods and technologies to improve the accuracy and sensitivity of bioanalytical assays.

 

India possesses a burgeoning and competitive bioanalytical services sector, in which Vipragen aims to deliver top-tier services to cater to the needs of both domestic and international clients within the pharmaceutical and biotechnology domains. Such services play a pivotal role in driving drug development forward, guaranteeing drug safety, and facilitating clinical research endeavors.