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:
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customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development
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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
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regulatory, scientific and technical excellence with a problem-solving approach
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compliance with all applicable EMA, FDA and ICH regulations
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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
