To meet the Pharma Industry Quality standards, a GMP Management System is in place since 1998. Our level of compliance has been challenged by regulatory inspections, as well as by our clients’ audits. All business areas, from analytical services to the production unit, are integrated with a clear focus on overall Quality Management System.
As a global CRO and CMO, many of our clients rely their outsourcing of analytical services in an accredited lab. An officially accredited ISO 17025 system is in place since 2002, being continuously challenged through the participation in Proficiency Tests Programs.
The analytical support to our clinical services, namely the assay of biosamples from BA/BE studies, needs a strong controlled and regulated Quality frame. In this scope, LEF is an OECD-GLP certified organization by Portuguese authority (INFARMED), since 1995, and GLP certified by Brazilian authority (ANVISA), since 2008.
Our organization is committed to act responsibly from an environmental point of view, adopting behaviors that enhance the rational use of resources and create efficiencies that will result in continuous improvement of its environmental performance.