Harlan Laboratories operates in accordance with GLP, GMP and ISO 17025 as well as national standards for pharmaceutical testing.
We attend regular meetings with the authorities as well as with international QA organizations to ensure that we meet the changing expectations and trends.
Harlan Laboratories has over 30 years experience in the performance of GLP studies of almost all types and categories.
Studies are performed according to the OECD GLP principles under national GLP laws, and our facilities are included within national GLP monitoring authority inspection programs. Studies performed at our test facilities are accepted worldwide under the OECD Mutual Acceptance of Data (MAD) agreement. Field studies are performed to comply with GLP and the standards laid down in the Commission Directive 93/71 EEC for efficacy testing, GEP.
Harlan Laboratories operates GMP-compliant laboratories in compliance with local US and European GMP regulations.