Bio Analytical Studies
Bio Analytical Studies
globeELIXIR have a decade long experience in offering comprehensive range of Bio-Analytical services, advanced facilities, equipment’s and highly-trained personnel for custom method development, assay validation, and sample analysis using modern to support Pharmaceutical and Generic Drug Development.
globeELIXIR has the competency to handle liquid-liquid extractions, solid-phase extractions and pre-column | post-column derivatization procedures, Chiral separation of optical isomers as well as Conjugate and non-Conjugate drug level estimation.
The Bio-Analytical Team has developed a deep understanding of the specific regulatory requirements of international regulatory agencies.
Our method data bank has over hundreds of new drug assays, with the standards set by international regulatory authorities.
All analytical methods developed and validated at globeELIXIR are compliant with latest international regulatory requirements with assurance of precision recovery and stability checks. We offer the flexibility and specialized expertise to either transfer your clinical assay or develop a method from scratch and validate the assay for the bio-analysis in a cost effective and timely manner. Our staff has developed Bio-Analytical methods including routinely quantifying levels.
globeELIXIR has developed hundreds of validated assays for multiple analytes, metabolites, prodrugs and light and temperature-sensitive compounds in various biological matrices. Using the literature support and experience in similar molecules, our method development team discusses and develops the research plan.
All the method validations are performed according to Good Laboratory Practices (GLP), regulatory guidance and in-house SOPs to ensure that the developed assays demonstrated linearity, recovery, reproducibility, specificity, accuracy and stability under all conditions.
Our significant expertise in stringent Bio-Analytical methodologies and processes promises the fast and rapid sample processing throughput and quality data. At globeELIXIR perform Bio analysis in line with international regulatory requirements with constant check from In Process Quality Control Team.