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).
GEM FORLAB – ABLE Biosciences Good Laboratory Practice Certification
On December 19th, 2018, GEM FORLAB – ABLE Biosciences obtained the GLP certification renewal within the following areas of expertise:
1) PHYSICAL-CHEMICAL TESTING
6) RESIDUE STUDIES
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).
GEM FORLAB – 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
GEM FORLAB – ABLE Biosciences Quality Management System
In GEM FORLAB all the activities, even those not regulated, are performed following a high quality system inspired to GLP principles.