Regulatory compliance

Regulatory compliance

Being present in the main developed markets of the world, requires efficiency and the highest level of quality, safety, health and environmental standards. ESTEVE has always been highly commited to these areas. Evidence of this are all certifications obtained:

ISO 9001 (quality), OHSAS 18001 (health and safety), ISO 14001 (environmental). The implementation and compliance of these standards is verified through annual audits, both internal and external, by prestigious institutions.

We have established the main international regulations such as GMP (international guide to good manufacturing practices), GLPs (international directory of Good Laboratory Practice) and GCP (International guide to good clinical practice).

In addition we prepare and manage the annual inventory of greenhouse gases according to the Green House Gas Protocol (GHGP) aimed at reducing CO2 emissions.

Importantly, the group's API subsidiary Esteve Química is the first company in its sector in Spain to ever obtain approval from the Japanese Health Agency (KIKO). This authorization, indispensable to commercialize active substances, comes on top of the approval already obtained from the North American Health Authorities (FDA) for all our production centers.

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