ClinSync E-LIBRARY

ClinSync 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 LC-MS/MS to support Pharmaceutical NCE and Generic Drug Development.

Bio-Analytical Team has developed a deep understanding of the specific regulatory requirements of international regulatory agencies such as FDA, EMEA, NPRA, ANVISA, TGA and DCGI.

Our method data bank has over 100+ new drug assays, ⁣with the standards set by international regulatory authorities.

List of Validated Methods

Method Development and Method Validation

Chemical and biological drug concentration measurement and their associated metabolites are key to pivotal nonclinical toxicokinetic (TK) and pharmacokinetic (PK) studies and clinical Phase II-IV clinical trials. The results from well-characterized, appropriately validated, and documented methods ensure reliable data to support regulatory decisions for your program.

Method Development

ClinSync have Bioanalytical method development for small molecules must carefully define the design, operating conditions, limitations, and suitability of a method that is ultimately optimized for method validation. Method development involves finding the best procedures and conditions for extracting and detecting the analyte and/or its metabolites, understanding that each bioanalytical technique has its own characteristics and will vary from analyte to analyte. Our scientists are constantly developing and validating methods for both small molecules and biologics across many technology platforms including LC/MS/MS.

Method Validation

It is essential to employ well-characterized fully validated bioanalytical methods to ensure reliable results to make those critical go/no-go decisions along the drug development journey. Each bioanalytical method is validated according to applicable health agency guidance documents by our scientists so that it is appropriate for the intended meaning of a study and yields robust data for specificity, precision, and accuracy.