We in GENERI BIOTECH believe that sustainable development of our company can be achieved also through permanent improving processes. Below there is a list of standards for which GENERI BIOTECH is certified (accredited).
ISO 9001:2016 – general standard (view certificate)
EN ISO 13485 ed.2:2016 – standard for development and manufacturing CE IVD products (view certificate)
ISO 17025 – standard for non-GxP testing (view certificate)
GLP – Good laboratory practice – system audited by national drug and administration authority. Laboratory tests under GLP are mostly required by companies developing new drugs. (view certificate)
GMP – Good manufacturing practice – system audited by national drug and administration authority. It is required for those tests that are ordered by pharma companies to release a batch of a drug to the market. (view certificate, view certificate no.2)
GENERI BIOTECH is a holder of GMO Authorization according to Directive 2009/41/EC on contained use of genetically modified micro-organisms.