Development & analytical method validation

Bioanalytical laboratory is equipped with the most modern and sensitive bioanalytical instruments. All instruments are qualified, calibrated, and maintained in optimal conditional to assure the data quality.

Method Development

GRC analytical lab develops wide Range of analytical to detect and measure drugs and metabolites in biological matrices such as: plasma, urine , blood and saliva using liquid –liquid extractions, solid phase extractions and protein precipitation techniques. HPLC and LC-MS/MS techniques are the methods of choice.

Method Validation

Methods are Validated adhering  to the US-FDA ,EMEA and local Bioanalytical Guidance and following our SOPs that meet good laboratory practices (GLP).as per validation, protocol, specificity, selectivity, linearity, accuracy, precision, sensitivity, stability, recovery, dilution integrity, and system suitability are evaluated. All the generated results are reported and tabulated in the method validation report. In this context, more than 200 methods were reported in our bioequivalence and bioavailability reports accepted all over the world.