Accelerating access to tomorrow’s life-changing therapies through analytical excellence

We specialise in the analytical development of complex and emerging therapeutic modalities. We design and implement customised analytical strategies to assess the quality, safety and efficacy of drug candidates.

Expertise across modalities — with depth and precision

We provide full analytical support for innovative medicines, including:

Whether the stage of your molecule development, from discovery to patients, our experts design analytical solutions aligned with regulatory expectations and adapted to your innovation.

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Our Expertise

Early Phase

  • Custom analytical method development aligned with ICH guidelines
  • GLP/GMP-compliant environment to anticipate smooth method validation
  • Reliable data for preclinical dossiers, ensuring safety and efficacy from the start

Preclinical Phase

  • GLP-certified bioanalysis: active substance assay, PK/TK studies, biomarker analysis, immunogenicity assessment
  • Additional tests: in-use stability, drug interaction studies
  • CMC support: robust method development for DS/DP, preliminary stability studies, product characterisation, batch analysis
  • Formulation support and risk mitigation through integrated expertise

Clinical Phase (I, II, III)

  • CMC Services (GMP): full analytical support (method development and validation), batch testing and stability studies
  • Bioanalytical Services (GLP): PK/TK studies, biomarker analysis, immunogenicity assessment
  • Flexible support for adaptive protocols and complete regulatory documentation (EMA/FDA)

Marketing Authorisation

  • Method optimisation and validation for commercial production
  • Analysis of pilot and PPQ batches, preparation of Certificates of Analysis (CoA)
  • Long-term stability studies, commercial batch testing, and result release
  • Analytical support for MAA submissions, GMP-certified with statistical data support

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Build science that matters

Join QA to make a global impact: every role here accelerates safe, effective treatments for patients worldwide.

As a discreet but vital link between research and patients, we take pride in our responsibility and that’s what makes our work so meaningful.

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About Quality Assistance

With over 40 years of experience, Quality Assistance is a leading European CRO focused on analytical sciences for innovative drug development. Based in Belgium and GxP-certified, the company provides EMA- and FDA-compliant services from a fully integrated, single-site facility equipped with a comprehensive suite of state-of-the-art technologies.

More about Quality Assistance
  • 280+ high qualified profiles
  • 2000+ contributions to innovative drug projects
  • 100% approval rate at first submission (FDA/EMA)
  • 40+ years of independent expertise