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;
9.4) 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: email@example.com
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.
GEM FORLAB Clinical diagnostic authorization
Gem Forlab has recently received the authorization for clinical diagnosis as private laboratory from Regione Piemonte (DD 1328/A1414C/2020).
Gem Forlab is also authorized to perform diagnostic assessments at high technological and professional level in the field of Microbiology and Serumimmunology.
By now Gem Forlab obtained the accreditation of the molecular method for the detection of Sars-CoV-2 in oropharyngeal swabs by the Department of Microbiology and Virology of the AOU Città della salute e della scienza di Torino as regional reference laboratory.
For more details please visit the dedicated section here.