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.
REGULATORY EXCELLENCE: A COMMITMENT TO QUALITY
Global Standards Compliance
At QUATRE, we operate under the highest regulatory standards, ensuring safety, quality, and compliance at every step.
Guided by World-Class Authorities
- EMA
- FDA
Harmonized with Leading Pharmacopoeias
- Eu.Ph.
- USP
Our processes and products meet the most stringent safety measures, driven by:
- Outstanding Quality Standards
- Rigorous Safety Protocols
- Full Regulatory Compliance
💡 Why This Matters
By adhering to these globally recognized guidelines, we ensure that your projects are in trusted hands, meeting all international requirements seamlessly.
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
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
EXCELLENCEE QC SERVICE FOR ATMPs
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.
