Centralise your analytics

       

Analytical development

Our services

For characterisation, identification, assays, impurities, potency, packaging, stability-indicating
methods and bioanalysis

  • Method development from scratch or fine-tuning of existing methods
  • Method qualification in accordance with protocols adapted to the development stage
  • Method validation according to protocols compliant with ICH, FDA and EMA requirements
  • Method transfer from/to your laboratory, in accordance with customised protocols including analyst training if needed

Wide expertise

Scientific soundness !

  • Over 30 years in NCEs
  • Over 15 years in Biologics
  • All laboratories on one site
  • Extensive experience and state-of-the-art facilities and equipment
  • > 150 projects a year

Analysis and reporting

  • Statistical analysis of validation results (including total error concept)
  • SOPs and development, transfer, qualification and validation reports adapted to your needs

All matrices

  • Drug substances
  • Drug products
  • In-process samples
  • Starting materials
  • Excipients
  • Packaging materials
  • (Pre) Clinical batches
  • Biological fluids and tissues

Communication

  • One dedicated Account Coordinator, your «hot line» for any questions you have
  • Drawing up and optimization of protocols with our Analytical Team Managers
  • Technical meetings with our Scientists at each critical step

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You can download the brochure
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