Method Development

Method Development

EUROLAB It is at your service with its expert team, state-of-the-art laboratories and extensive experience in the development of analytical, bioanalytical and microbiological methods.

Method Development

Method Development

We have experience in developing analytical methods for our entire analytical portfolio and for the entire life cycle of a drug. Typical applications:

  • Quality control of APIs, starting material, intermediates, finished products, impurities and spoilage products
  • Stability test
  • Characterization of substances, identification of impurities and degradation products
  • Forced demolition work
  • Container closure test, removable and leaks
  • To support preliminary and clinical sample analysis

Method validity

During the method development phase, initial validation tests are performed to ensure that the method is reproducible and suitable for its intended use. When used in the GMP or GLP environment, the methods are formally validated against ICH Q2R1 guidelines, including verification protocols and preparation of reports.

To provide low cost solutions EUROLABoffers validation programs tailored to the drug's development phase and in line with the customer's internal quality requirements.

EUROLAB, with its highly expert team and internationally accredited laboratories, Method Development It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.

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