Driving Product and Process Quality through the project lifetime


Our Analytical Method Development and Validation and Quality Control Departments exceed clients’ expectations by providing a wide range of in house analytical methods.

We are ready to work with you to develop and/or transfer methods at all project stages. An experienced and dedicated team will drive your analytical methods development or transfer while applying detailed regulatory knowhow and the latest innovation. We have made our passion for excellence in quality a priority, which is why our team dedicates extraordinary attention and precision to each project to ensure success.

Analytical Method Lifecycle: development or transfer from client at any stage, qualification and validation for release or stability testing.

 

Development
Development
Qualification
Qualification
Validation
Validation

EQUIPMENT PLATFORMS

Equivalent key equipment in both nonGMP and GMP laboratories

  • Extensive HPLC/UPLC platforms with multiple detectors (DAD, FLD, ECSD)
  • Mass spectrometer Waters Xevo G2XS ESI-QTof
  • Capillary Electropheresis (Maurice)
  • Spectophotometry UV/FTIR
  • 96/384 Plate readers
  • Bioassay suites
  • Microbiology laboratories
  • Wet laboratories for electrophoresis and immunoblotting
  • Stability chambers
  • LIMS GMP/nonGMP

Aplications:

  • Method development, qualification and validation
  • Method transfer: into 3P and out from 3P at any stages of lifecycle
  • GMP DS and DP Release testing from Phase I to Commercial
  • nonGMP testing of intermediates and final products
  • Process development analytical support
  • Forced degradation studies
  • Formulation Development
  • Stability studies
  • Product and/or Reference Standard Characterisation
  • Comparability studies (site change/Biosimilars)