Acting as monitoring scientist, we verify the GLP compliance of the main documents in a GLP study (such as protocol and final report) according to OECD  (ENV/MC/CHEM(98)17) and FDA (21 CFR 58) standards. We also provide support on process and facility inspections, as well as on raw data and SOP verification in the studies we are involved in.

We provide advice and assistance on setting up, monitoring and reporting multi-site studies.

Before selecting a Contract Research Organization (CRO) or during study performance, we conduct an on-site inspection of the GLP compliance status of the organization at the sponsor’s request.

We offer GLP training and refresher training courses for your staff.  We customize this training to meet your organizational focus/needs.