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.
We implement and adapt our in-house robust Quality Control (QC) systems that guarantee and maintain consistency of our customers' final product throughout the process. Our team supports your analytical project from method development and transfer strategy to validation, release testings and stability testings. Our facilities include a microbiology lab to test the environment controls and all aseptic process validation samples.
When it comes to customer satisfaction - transparency, flexibility and adaptability matter. This is why our QC team works closely with the QA and Project Management teams and have developed a strong network of GMP-certified analytical partners.
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.
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).