INTEGRATED QUALITY
CONTROL SERVICE
FOR ATMPs
OUR SERVICES
We offer an integrated Quality Control service for ATMPs, from analytical method development to validation and routine testing, providing full support throughout the product life cycle. We adapt to the specific needs of each client to ensure accurate and reliable results.
EFFICENT QUALITY CONTROL: speed, accuracy, safety and low cost.
Our streamlined and efficient approach to Quality Control analysis enables our clients to bring their products to market quickly and efficiently, without compromising accuracy and safety at an affordable cost.
STRICT GUIELINES OF REGULATOY AGENCIES
We ensure that our analyses comply with the strict guidelines of Regulatory Agencies such as:
• EMA (European Medicines Agency).
• FDA (Food and Drug Administration).
Currently, we are immersed in the process of obtaining the GMP (Good Manufacturing Practices, from the Spanish Agency of Medicines and Health Products – AMEPS) demonstrating our continuous commitment to excellence in manufacturing and Quality Control.
STAGES & PROVISIONS
Basic R&D
Method development
Scientific consulting
Quantitative testing
Impurity profiling
System Suitability Testing
Preclinical
Product characterization
QC Assay set-up
Preliminary studies for MoA
Cytotoxicity
Immunogenicity
IND acceptance
Safety assays
Identity assays
Purity assays
Stability studies
Method qualification
Clinical Phases
Phase I: GMP-like
Phase II-III: GMP*
Potency assays
Validations
Batch Release
* according to EMA/FDA regulations
POTENCY ASSAYS
SAFETY ASSAYS
PURTIY ASSAYS
CELL BANKING
If you would like more information or have any questions, please don’t hesitate to contact us. We are here to help and answer all your inquiries.
PERSONALIZED
CUSTOMER SUPPORT
TROUBLESHOOTING
HIGH-TECH ENHANCEMENT
INNOVATING QC SUPPORT & VALIDATION
COLLABORATIVE FRAMEWORK
Quality Advanced Therapies Research, S.L. holds the Authorizations for Type 2 contained use Facilities (A/ES/23/I-01 and A/ES/23/I-50) to work with genetically modified organisms (Activity Authorizations A/ES/23/01 and A/ES/23/140) granted by the Interministerial Council on Genetically Modified Organisms (CIOMG), affiliated with the Ministry of Agriculture, Fisheries, and Food of Spanish Government.
