We work every day to provide the highest quality of services and guarantee identity, purity, stability, safety and potency of your cells. We are GMP-certified and our Quality Control services are performed in compliance with the following requirements: ICH Q2 (R1), European and US pharmacopeia, FDA and EMA.

Quality Control

We provide confidence that all systems and elements influencing the quality of our customers' product are working as expected. We are GMP-certified and our quality system is designed to strictly meet the requirements of ATMP 1394/2007. Every single part of our organisation, from the infrastructures to people and operations, is regulated by our quality system. Our Quality Assurance (QA) team provides directions throughout a customer project to ensure its efficient management and successful execution, while keeping the highest levels of transparency, consistency and reproducibility. All batch records are reviewed in real time.

Release Testings

Release Testings

Environment Testings

Environment Testings

Genetic Characterization

Genetic Characterization

Method Development

Method Development

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Quality Assurance

We provide confidence that all systems and elements influencing the quality of our customers' product are working as expected. We are GMP-certified and our quality system is designed to strictly meet the requirements of ATMP 1394/2007. Every single part of our organisation, from the infrastructures to people and operations, is regulated by our quality system. Our Quality Assurance (QA) team provides directions throughout a customer project to ensure its efficient management and successful execution, while keeping the highest levels of transparency, consistency and reproducibility. All batch records are reviewed in real time.

Continuous Improvement Management

Continuous Improvement Management

Manufacturing Management

Manufacturing Management

Staff Management

Staff Management

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Qualified Person and Regulatory Support

Our team includes two Qualified Persons with a strong track record working every day to continuously support the safe and successful releases of our customers' cell therapy products. Our services include clinical trial authorisation, clinical protocol writing, consent form and custom files (import/export).

Safe Release

Safe Release