Our dedicated team of experts and extensive equipment capabilities enable us to deliver quality analytical methods throughout all phases of clinical development, GMP scale up and commercialization in line with ICH and FDA/MHRA/EMEA requirements.
Our technical team develop, qualify, transfer, and validate analytical methods as part of our integrated approach to process and product development. This enables full analytical support for regulatory starting materials (RSM) and in-process control strategies in addition to intermediate and API characterization with the flexibility needed for phase appropriate development and GMP manufacturing of drug candidates.
- Method development, qualification, validation, and transfer in compliance with global regulatory guidelines/ICH Q2(R1)
- ICH stability including photostability
- Forced degradation studies
- Impurity isolation, identification, and characterization.
- Characterization of APIs and precursors
- Reference material program
- cGMP Regulatory Starting Material assessment
- Potential mutagenic impurity (PMI) & nitrosamine assessment and testing
Our global analytical development capabilities facilitate the full range of analytical techniques required to test for the purity, identity, potency, chiral purity and safety of the investigational product at all clinical phases.
We use state-of-the-art spectrometry, spectroscopy, chromatography, and characterization instrumentation to deliver high quality methods to the specifications required:
- UPLC with TUV, PDA, and QDa detectors
- HPLC with VWD, PDA, CAD, MALS, RI, FD, and MS detectors
- GC (direct and headspace injection) with FI, EC, and MS detectors
- IC with conductivity and UV detectors
- Spectroscopy (IR, NMR, ICP-OES, ICP-MS, UV/Vis, Polarimeter)
- Physical Characterization (TGA, DSC, XRPD and Particle Size Analyzer)
- Thermal Analysis (TGA & DSC) and Wet Chemistry (TOC, Titrators, RI)