Analytical Development

The analytical methods created during development are a key component of the Chemistry, Manufacturing and Controls (CMC) section of product’s regulatory filings. Inconsistencies in the analytical method can hinder product and process development, thus delaying submission for regulatory approval and thereby delaying product launch. Oncogen’s analytical development team has capabilities to do method development, optimization & transfer of analytical methods to any site across the globe. All the methods are developed & validated following recommendations of USFDA, ICH, USP & often “fit for purpose” for IND, NDA & ANDA submissions. The specific expertise lies in identifying discriminatory dissolution methods, Biorelevant methods, ICH stability, determination of degradation pathways, & establishment of stability indicating analytical methods for all formulations. 

 

 

A special focus on reverse engineering comes from our infrastructure which has high-end instruments like XRD, DCS, TGA, DVS, NMR, Mass, UPLC, Malvern particle sizer, ICP-MS etc & subject matter experts in solid phase characterization, with this set-up, Oncogen can provide comprehensive characterization support to all the product development phases with shortest plausible lead time.