GENERI BIOTECH is a GLP/GMP-certified quality-focused provider of outsourced services to the pharmaceutical, biotechnology and medical device industries, mostly specializing in (pre)clinical development.
Our quality system meets the most stringent requirements from regulatory authorities.
GLP refers to a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical and pharmaceuticals non-clinical safety tests. Laboratory tests under GLP are mostly required by companies developing new drugs.
GLP system is audited by national drug and administration authority.
In March 2018, GENERI BIOTECH obtained Certificate of good laboratory practice with scope of activities: Non-clinical studies others – Molecular biological methods (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.
GMP system is audited by national drug and administration authority.