GTMPs (Gene Therapy Medicinal Products)

Quality Assistance offers extensive experience with analytical development and validation and GMP/GLP compliant laboratories to assist in the development of your gene therapy medicinal products.

Your analytical partner providing:

  • customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development

  • a full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Cell Biology, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods

  • regulatory, scientific and technical excellence with a problem-solving approach

  • compliance with all applicable EMA, FDA and ICH regulations

  • GMP, GLP, GCLP/GCP environment

Your one-stop shop for analytical services

Outsource your analytical needs on one site for more efficiency including:

  • Analytical development
  • Validation of analytical methods as per ICH guidelines
  • Product characterisation
  • Stability studies
  • Batch testing
  • Bioanalytical services
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