SmartBio Analytics, a CRO specialized in bioanalytical services, has obtained official Good Laboratory Practice (GLP) certification, becoming the first bioanalytical laboratory of its kind in the Community of Madrid authorized to conduct regulated preclinical studies.
The certification was granted by the Directorate-General for Inspection and Healthcare Regulation of the Community of Madrid following an on-site inspection on April 8–9, 2025. The certificate — reference number BPLI/25.05/51-CM — is valid until April 2027.
This achievement addresses a growing need within the regional biomedical ecosystem: having local capabilities to generate analytical data compliant with OECD and EU regulatory standards and fully valid for submission in regulated preclinical programs.
The certification covers Category 8.1: analysis of drug levels and their metabolites in biological specimens, where SmartBio Analytics applies advanced LC-MS/MS mass spectrometry methodologies, with a focus on small molecules, peptides, and oligonucleotides.
“This milestone strengthens our commitment to regulatory quality and allows us to deliver traceable, reproducible data that can be accepted by health authorities worldwide,” said Rafael Terán, General Manager at SmartBio Analytics. “It also reinforces Madrid’s positioning as a strategic hub for biopharmaceutical development.”
Since its foundation, SmartBio Analytics has been committed to a rigorous and agile scientific model aligned with the real needs of the industry, building collaborations with pharmaceutical companies, biotech firms, and CROs both nationally and internationally.
