Our dedicated ARD team has a thorough understanding of the latest regulatory requirements, relevant chemistry and analytical knowledge which are essential in developing efficient, accurate and robust analytical methods.

The ARD team interacts closely with PRD team to understand process requirements in order to  quickly develop appropriate analytical methods for monitoring reactions and final product testing. Our team has extensive experience and knowledge in developing analytical methods for chiral compounds, as well as in developing methods for trace residue detection such as genotoxic impurities (GTIs) and nitrosamine detection.

The analytical methods are validated by a team under GMP with QA supervision and in accordance with the appropriate phase requirements and ICH norms. During the validation of the analytical method, the team performs all activities as required by the client, including the review and approval of the validation protocol and report.

Our ARD service includes but are not limited to:

• Analytical method development and validation
• Analytical method transfer
• Stability studies
• Reference standard characterization
• Preparation of impurities and structural identification
• Method development and method validation for GTIs
• Product release testing
• Characterization of physicochemical properties
• Microbiological testing
• Design quality control strategy (impurity control, quality study for IND/NDA filing, QRA, QbD study etc)
• Method development report in accordance with IND/NDA requirements

Partial list of key analytical instruments we use:

• Chromatography: HPLC, UPLC, GC, IC, SFC, LC-CAD, LC-ELSD, PREP-LC
• Mass spectrometry: LCMS, GCMS, HRMS
• Identification: FT-IR, LCMS, NMR, HRMS
• Elemental impurities: ICP-OES, ICP-MS
• General testing: KF, Titration, UV, LOD, cKF
• Solid state testing: XRPD, DSC, TGA, DVS, PSD