Analytical Development

Whether it is for characterisation, identification, assays, elemental impurities, potency, packaging, stability or bioanalysis, Quality Assistance offers its expertise for the development, transfer and validation of analytical methods. For every analytical challenge, we are able to provide a customised approach to help you overcome it and move your product registration process forward.

Quality Assistance combines skilled teams, a product-dedicated approach as well as state-of-the-art EMA/FDA audited facilities, equipment and software to design fast and reliable analytical methods.

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Analytical Development

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Our expertise

Our services

  • 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

Customer support

  • Know-how and experience to understand your needs

  • Customised solutions in order to evaluate the quality, safety and efficacy of your product:

    • Definition of analytical protocols

    • Development and validation of new analytical methods

    • All the analytical services required by EMA and FDA regulations

  • Efficient project management and communication

  • GMP, GLP, GCLP/GCP environment