Our state-of-the-art analytical facilities with modern instruments and CFR part 11 compliant software allows to serve all your analytical method development and validation needs.
Our team is very well versed with the recent trends in analytical research and delivers research solutions to biopharmaceutical industries. We offer wide range of customized analytical and bioanalytical research services to our clients for drug discovery and development research. Following are some of the capabilities and services offered:
Analytical method development and validation (NCE, API and Formulations)
Impurity profiling for NCE's, API and Key Starting Materials
Structural elucidation
Analysis of extractable and leachable from the drug packaging material
Establishment of stability profile as per ICH guidelines (API, excipients and formulations)
Finalization of the physical and chemical characterization/specification for the intermediates and finished products.
Determination of disintegration / dissolution profile in drug formulations
Forced degradation studies (API, excipients and formulations)
Tablet hardness, thickness, disintegration and friability
Conduct bioanalytical chemistry testing, method development and validation (blood plasma) using LC-MS/MS
Develop suitable analytical methods for in-process control / checks in the intermediate stages of drug synthesis
Analytical support to the medicinal chemistry and process research team for the development of the NCE
Routine analysis of the raw materials, intermediates and the finished product (API, excipients and formulations)
Prepare the analytical reports (ICH / FDA or as per clients format)
Prepare analytical documents required for the technology transfer
