GEM FORLAB includes ABLE Biosciences, a GLP certified Test Facility also included by AIFA (Agenzia Italiana del Farmaco/ Italian Medicines Agency) in OsSC register of Private Laboratories qualified to perform analysis on samples coming from clinical trials (phase I-II-III).
ABLE Biosciences Good Laboratory Practice Certification
On March 21st, 2016, ABLE Biosciences obtained the GLP certification renewal within the following areas of expertise:
1) PHYSICAL-CHEMICAL TESTING (as concern Methods Validation)
9) OTHER (SPECIFY)
9.4) BIOTECHNOLOGY AND MOLECULAR BIOLOGY STUDIES
9.7) PHARMACOKINETICS/TOXICOKINETICS AND ADME STUDIES
ABLE Biosciences has its own GLP archive.
Computerized systems and software, employed for PK/TK and Biomarkers studies, are internally validated according to regulatory authorities requirements (US 21CFR Part11, GAMP guidelines).
ABLE Biosciences Good Clinical Practice
On October the 1st, 2014, following the accreditation procedures in accordance with artt. 1 and 2 of DM 16 Marzo 1998, AIFA included ABLE Biosciences in OsSC register of Private Laboratories qualified to perform analysis on samples derived from drug clinical trials (phase I-II-III).
We encourage clients to audit our facilities.
Should you need any additional information, please do not hesitate to contact us: firstname.lastname@example.org
ABLE Biosciences Quality Management System
In ABLE Biosciences all the activities, even those not regulated, are performed following a high quality system inspired to GLP principles.