LAB Research's Hungarian site successfully completes GLP certificate i...
LAVAL, QC, Oct. 23 /CNW Telbec/ - LAB Research Inc. ("LRI" or "LAB Research") (TSX: LRI), a Canadian-based global non-clinical contract research organization ("CRO"), announced that its Hungarian site ("LAB Hungary") successfully completed its biennial Good Laboratory Practices ("GLP") inspection by the Hungarian authorities (OGYI: National Institute of Pharmacy) (the "Inspection"). Consequently, its GLP certificate remains in full force. In addition, to the Inspection, the site was also subject to a favourable audit of the chronic inhalation studies performed for one of its sponsors (the "Audit"), last August by the US Food and Drug Administration ("FDA"). The Audit was conducted in conjunction with the OGYI and did not alter the GLP status of the site.
The Inspection --------------
The Inspection was concluded yesterday and no major findings were noted by the authorities. As it is customary, the GLP compliance certificate will be issued by the authorities after submission by LAB Hungary and review and acceptance by the authorities of corrective measures addressing the minor findings and observations noted during the course of the 9-day Inspection. We anticipate the certificate to be formally renewed in the coming months as no major findings were noted. In the interim, the GLP status of the site remains unchanged and in full standing. The biennial Inspection was performed in conformity with the Organization for Economic Co-Operation and Development ("OECD") GLP Compliance Monitoring Requirements.
The FDA Audit -------------
The Audit performed last August, was led by the OGYI with the participation of a senior inspection representative from the FDA. The Audit focused primarily on the two studies which had been previously rejected by the FDA earlier this year. As part of the Audit, the inspectors also assessed the GLP status of the site with particular emphasis on the areas or activities which were specific to the chronic studies. The outcome of both the Inspection and the Audit were positive for LAB Hungary as the site remained in full compliance of its GLP certificate. Mr. Luc Mainville, President and Chief Executive Officer stated "While all European and North American laboratories are dealing with more stringent regulatory scrutiny, the results of these regulatory Audit/Inspection are highly satisfactory and send a clear message to our valued clientele regarding the GLP status of our Hungarian operation. Of particular importance was the fact that both regulatory teams complimented management on the changes that had been implemented in Hungary since the last GLP Inspection which occurred in 2006. As the GLP status of our sites represents the single most important criteria for ensuring the success of our activities, we intend to eagerly leverage these favourable events to boost the financial performance of both our Hungarian operation and of the LAB Research platform." "We take great pride in the fact that our Hungarian GLP certificate remains in full force following the recent Inspection while several larger CRO's have been recently subject to less favourable reviews. We invite all our clients to visit each of our sites to assess for themselves the quality and regulatory compliance of our operations" added Mr. Mainville. LAB Research Denmark will also be subject to its regular biennial GLP inspection by the Danish authorities later this month.
About LAB Research Inc.
LAB Research is a global non-clinical contract research organization that provides contract research services to the pharmaceutical, biotechnology, agro-chemical, petro-chemical and industrial markets. LAB Research supports the development of its customers' products from three state-of-the-art facilities located in Canada, Denmark and Hungary. LAB Research's shares trade on the TSX under the symbol "LRI", with 18.1 million shares outstanding. %SEDAR: 00023798EF
/For further information: LAB Research Inc.: Luc Mainville, Chief Executive Officer, (450) 973-2240, Ext.: 1206, firstname.lastname@example.org
Posted: October 2008