Oroxcell, a contract research organization (CRO) specialized in the invention and development of alternative approaches for research establishments and industrial companies, has announced that it has been granted good laboratory practice (GLP) certification under the 2004/9/EU directive (safety testing), following an inspection by the French Health and Safety Agency (Agence Française de Sécurité Sanitaire des Produits de Santé - Afssaps).
The inspection was carried out on January 18 and 19 this year at the company's premises in the Biocitech life sciences technology park, where it has been established since 2004.
The inspection resulted in Oroxcell's laboratories receiving Grade A GLP compliance certification, which relates to tests on medicines for human use and cosmetics and covers the following areas of activity: skin irritation and corrosion, validation of bioanalytical methods, bioanalysis, and cytochrome induction and inhibition.
GLP certification will enable Oroxcell to strengthen its position on the regulatory market of alternative methods, which is booming. In effect, the relevant European directives encourage researchers to switch to new models that are alternatives to the use of laboratory animals in all areas, and especially in the field of cosmetics, where animal testing is now banned.
Oroxcell applies its culture of innovation to the development, validation and setting up the production process of alternatives to the use of laboratory animals, and its expertise in bioanalysis and cell and tissue testing to the evaluation of the bioavailability and toxicity of products.
"Oroxcell is an innovative company operating at the crossroads between several disciplines, which enables it to reconcile the benefits of its different sectors of activity and drive the innovation process further," said the President of Biocitech, Jean-François Boussard.
Boussard continued, "It has developed novel and advanced technologies and has now given its business added value with this certification. The park's supportive environment and its ultra-modern and safe premises have helped Oroxcell achieve this distinction. We congratulate the whole team on attaining this new milestone in their development."
"Oroxcell knows how to innovate, develop, internationally validate and industrialize alternative testing methods," noted Oroxcell's chairman and scientific director, Jean Pachot.
Pachot continued, "Oroxcell has secured this GLP certification through substantial human and financial investment, reflecting its longstanding commitment to improving quality and developing innovation. This certification will enable us to push ahead with our development projects at the service of human health and the safety of our clients' products by offering them a real guarantee."
And he added: "With its integrated, automated platform, Oroxcell is recognized as the European leader in the exclusive provision of alternative methods. With this Afssaps certification, the company becomes an indispensable player in the implementation of its clients' projects."