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Clinical Assay/ Bio-Analysis AXIS Clinicals offers a comprehensive range of Bioanalytical services, advanced facilities and equipment, and highly-trained personnel for custom method development, assay validation, and sample analysis using state-of-the-art LC/MS/MS and ICP-OES Bioanalytical facility. Our competencies 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. AXIS Clinicals Bioanalytical Team has developed a deep understanding of the specific regulatory requirements of international regulatory agencies such as FDA, EMEA, ANVISA, WHO, MCC, TGA and DCGI. AXIS Bioanalytical Unit has developed over 230+ new drug assays, with to standards set by international regulatory authorities. Method Development and Validation AXIS Clinicals offers the flexibility and experience to either transfer your clinical assay or develop a method from scratch and validate the assay for the bioanalysis. Our staff has developed Bioanalytical methods including routinely quantifying levels in pg/ml. We have methods 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. To ensure that clinical assays have demonstrated linearity, recovery, reproducibility, specificity, accuracy, and stability under all conditions, all the method validations are performed according to Good Laboratory Practices (GLP), regulatory guidance and in-house SOPs. Bio Sample Analysis Our expertise in stringent bioanalytical methodologies and processes ensures the sample processing throughput and quality data. The Bioanalysis is performed in line with international regulatory requirements with constant check from In Process Quality Control Team. We are performing Incurred Sample Reanalysis (ISR) in compliance with the protocol and regulatory requirement. |
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