Method Development and Validation

Method Development and Validation

Developing and Validating 180 Drug Substances and Drug Product Methods Each Year

Our analytical team has a proven track record in rapid method transfer, method development and method validation.

Working closely with our clients, we deliver robust, efficient, stability-indicating and fit-for-purpose analytical methods. We fully understand and comply with the analytical support demanded by regulatory authorities at each stage of the drug product lifecycle.

Our unique blend of experience, expertise, and focus enables us to deliver, reliable, information-rich methods to meet your exact requirements. Typical analytical techniques include, but are not limited to:

  • HPLC and U(H)PLC
  • Ion Chromotography
  • Q-NMR
  • Dissolution (USP apparatus 1 and 2)
  • LC-MS / GC-MS
  • Particle size by laser diffraction
  • GC
  • Volumetric/ Coulometric KF
  • XRPD
  • Potentiometric Titration
  • UV Spectrophotometry
  • Fluoresence Spectrophotometry
  • ICP-MS

Utilising the extensive library of in-house methods, statistical exploration tools, and emerging analytical technologies, such as UPLC™ and Empower 2, we can reduce your method development, validation time and associated costs while generating accurate and reliable data.

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