Certifications

Naobios: GMP-certified CDMO with authorizations to handle sensitive products

quality_assurance

The site is licensed by the ANSM (Agence Nationale de Sécurité du Médicament – French regulatory agency for medicinal products safety) and activities comply with EU-GMP (European Good Manufacturing Practices).

Cells and viruses can be handled in our BSL2 (biosafety level 2) and BSL2+ biocontainment laboratories and a BSL3 laboratory is currently being implemented. The site was also granted regulatory authorizations to handle GMO (Genetically Modified Organisms) which allows for sensitive products to be safely handled in our facilities.

GMP activities were licensed by the ANSM for the manufacture of API (Active Pharmaceutical Ingredients). Corresponding certificates of GMP compliance were issued and are available on the EudraGMP website.

Naobios is recognized as a pharmaceutical establishment for manufacturing operations, a French pre-requisite to licensing for any Contract Manufacturing Organization. The site is registered (authorization F19/219) for the manufacture of Human Investigational Medicinal Product (IMP), also known as Investigational New Drugs (IND).