Analytical Method Development and Validation

Analytical Method Development and Validation

Companies strive to be more flexible and specialized to compete in the fine chemicals, pharmaceutical and biotech markets. Outsourcing certain activities such as development, validation and analytical controls enables them to increase their speed and efficiency in both routine analysis procedures and activities that require the development of new methods. 

Analytical Method Development and Validation

Outsourcing also enables them to cope with seasonal increases in these activities.

Our solution

EUROLABoffers analytical methods quality control, development and validation services for both raw materials and finished products. We work under the standards of European and American pharmacopoeias

Among others, we collaborate on projects on:

  • Development of analytical methods
  • Characterization of active pharmaceutical ingredients (APIs) for quality control or production of DMF (Drug Master File)
  • Dosage form analysis for quality control or pharmaceutical file development
  • Validation of different analytical methods

Our analytics services include:

  • Physical-chemical control
  • Stability studies under ICH
  • Validation of analytical methods

Highly specialized laboratories:

  • Liquid chromatography (HPLC-DAD, UPLC-DAD)
  • Gas chromatography (GC-MS, GC-FID)
  • Spectrophotometry (ICP, FT-IR, UV-VIS)

Our expertise and facilities allow us to participate in all stages of the development of chemical processes:

  • Fine chemistry process development
  • Magnification of chemical processes
  • Analytical method development and validation
  • Production under GMP

EUROLABhas been working with companies in the fine chemicals, pharmaceutical and biotechnology industries for over 15 years, providing services from the research phase to the product marketing phase. We work under global reference standards. We apply the highest confidentiality criteria.

benefits

  • Ensuring product quality and safety
  • Speed ​​up time consuming activities during project development
  • Increase the flexibility of human and material resources

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

WhatsApp