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.

A dedicated team drives your methods development and transfer activities by applying innovation, experience & regulatory requirements in order to build the highest quality and risk control into your products. We are ready to both develop or transfer the methods at all stages of your project.

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

 

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)