Quality systemOur quality system (QMS) ; our focus
Our focus and rigorous efforts are always reflected in the quality of our services. With trained and experienced teams, qualified facilities, validated methods and a licensed quality system (QMS), we offer services complying with applicable national and international regulatory guidelines.
As pharmaceutical companies, Clean Cells, Naobios and Biodextris maintain infrastructures which comply with GMP regulatory requirements to perform pharmaceutical operations as requested by our customers.
Our infrastructures consist of Biosaftey Level 2 and 3 (BSL2 and BSL3) laboratories for the quality control and cell culture activities and controlled-atmosphere areas for the manufacture of cell and virus banks. Storage areas are also part of our facilities for the long-term preservation of material at +5 +/- 3°C, -25 +/- 10°C, -80°C and in liquid & vapor phase LN2 dewars.
Our high-performance facility consists of BSL2 & BSL3 areas with a controlled atmosphere which ensures proper operation safety, total confinement and the preservation of material used for bioprocess development, manufacture of cell and virus banks and production of clinical lots.
Versatile GMP production, analytical instrumentation and facilities combined with an integral QMS system, administered by a vigilant quality team, ensuring manufactured products and analytical results are GMP compliant and are safe for clinical applications.
Observing the GMP regulatory framework
The observance of the GMP (Good Manufacturing Practices) regulatory framework is imperative to ensure the quality, reliability and safety of our services.
Competent regulatory authorities arrange periodic inspections of our quality system, ensuring compliance and issuing corresponding GMP licenses.