Navigation Links
Biotrial Bioanalytical Services (BBS) Proves Top-Quality Performance by Successfully Passing Another FDA Inspection
Date:5/13/2013

Laval, Quebec (PRWEB) May 13, 2013

Biotrial is pleased to announce that following an inspection of Biotrial Bioanalytical Services (BBS) located in Laval, Quebec by the Centre for Drug Evaluation and Research (CDER) division of the FDA, no FDA Form-483 was issued. The inspection was conducted over a five-day period during which the bioanalytical laboratory facilities, procedures, and study specific data were thoroughly reviewed.

BBS President, Michael Mancini, Ph.D., P.Chem., said, “We are particularly proud to share the information with our clients that the 2013 routine pre-approval inspection resulted in no observations and that it demonstrated that we have maintained our uncompromising commitment to quality. We have exciting development plans for the future and are ready to deliver outstanding services to our customers.’’

“We are very pleased to have obtained such a positive result,” said Jean-Marc Gandon, President and CEO, “especially since we know that we are in a globally competitive market; we have set the bar very high and shown that the bioanalytical services we deliver at BBS are exceptional. The fact that the FDA had no observations demonstrates a high level of conformity to the regulations, thereby assuring our customers that the studies performed at BBS are carried out with cutting-edge science, competence and state-of-the-art equipment – that is what we deliver.”

BBS is a GLP-certified laboratory accredited by the Standards Council of Canada (SCC), Canada’s national Good Laboratory Practices monitoring authority. In addition to the FDA inspections, the laboratory has been inspected by AGES (Austrian Agency for Health and Food Safety). BBS provides bioanalytical services to support clinical and non-clinical development, including method development & validation, feasibility studies, technology transfer, bioavailability & bioequivalence studies, as well as therapeutic drug monitoring.

BBS employs a group of highly skilled scientists, has more than 250 validated assays that include some of the most challenging methods, has numerous exclusive proprietary methods, 25,000 sq. ft. of cutting-edge laboratories and workstations, and over 21 mass spectrometers including state-of-the-art ABSciex API 6500.

About Biotrial
Founded in 1989, Biotrial is a leading CRO specialized in Early Development with a wide range of services from Non-Clinical Pharmacology, Phase I studies, Phase II-IV Trial Management, Bioanalysis, Oncology, Data Management, Biostatistics, ECG & Imaging Core Lab (QT/QTc Trials, Psychometric Testing, Imaging, EEG/PSG Assessment), Regulatory Affairs to Medical Writing.

Based in France, Belgium, the United Kingdom, Canada and the United States, Biotrial performs hundreds of studies a year and offers tailor-made solutions to Biotech and Pharmaceutical companies.

For further information, please contact Anne Peron on [+33] (0)2 99 599 191 or visit http://www.biotrial.com.

Read the full story at http://www.prweb.com/releases/2013/5/prweb10722707.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Biotrial, a Leading Provider of Drug Development Services, Has Completed its Acquisition of Warnex Bioanalytical Services Division
2. Biotrial, a Successful Leading CRO, Continues to Expand its Activities, Creating a Unique Neuroscience Pool of Talent and Capabilities: Biotrial Neuroscience
3. VaxyGen Assay Services, LLC Announces Launch of Custom Bioassay Services and Operations
4. Quammen Health Care Consultants Takes Over Information Technology Reins at Faith Regional Health Services
5. Ambry Genetics Launches Illumina MiSeq Next-Gen Sequencing Services
6. Sigma-Aldrich to Acquire BioReliance; Extending Its Reach into Biopharmaceutical Testing and Services
7. Oxford Finance Provides $15 Million Senior Secured Credit Facility to Private Equity Backed Healthcare Services Company
8. Thomson Reuters Cortellis Drives Drug Discovery and Development With Powerful New Web Services
9. Synteract Director of IT Services Toby Odenheim Speaking at March 2012 Outsourcing in Clinical Trials East Coast Conference
10. Providence Health & Services Inks Deal with Remedy Informatics for Orthopedic and Stroke Registries
11. PharmAthene Secures $7.5 Million Credit Facility From GE Capital, Healthcare Financial Services
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... June 23, 2016 , ... Supplyframe, the Industry ... Supplyframe Design Lab . Located in Pasadena, Calif., the Design Lab’s mission ... hardware projects are designed, built and brought to market. , The Design Lab ...
(Date:6/23/2016)... 2016  Blueprint Bio, a company dedicated to identifying, ... community, has closed its Series A funding round, according ... "We have received a commitment from Forentis Fund ... to meet our current goals," stated Matthew Nunez ... to complete validation on the current projects in our ...
(Date:6/23/2016)... ... June 23, 2016 , ... Regulatory Compliance Associates® ... provides a free webinar on Performing Quality Investigations: Getting to Root ... CT at no charge. , Incomplete investigations are still a major concern to ...
(Date:6/22/2016)... 22, 2016 Cell Applications, Inc. and ... to produce up to one billion human induced ... one week. These high-quality, consistent stem cells enable ... and spend more time doing meaningful, relevant research. ... high-volume manufacturing process that produces affordable, reliable HiPSC ...
Breaking Biology Technology:
(Date:3/31/2016)... March 31, 2016   ... or the "Company") LegacyXChange is excited to ... its soon to be launched online site for trading ... ) will also provide potential shareholders a sense ... technology to an industry that is notorious for fraud. ...
(Date:3/29/2016)... BOCA RATON, Florida , March 29, 2016 /PRNewswire/ ... ("LegacyXChange" or the "Company") LegacyXChange "LEGX" and SelectaDNA/CSI Protect ... Synthetic DNA in ink used in a variety of ... preventing theft. Buyers of originally created collectibles from athletes ... authenticity through forensic analysis of the DNA. ...
(Date:3/22/2016)... India , March 22, 2016 /PRNewswire/ ... market research report "Electronic Sensors Market for Consumer ... Proximity, & Others), Application (Communication & IT, ... Geography - Global Forecast to 2022", published ... industry is expected to reach USD 26.76 ...
Breaking Biology News(10 mins):