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)... TORONTO , June 23, 2016 /PRNewswire/ - ... Ontario biotechnology company, Propellon ... the development and commercialization of a portfolio of ... cancers. Epigenetic targets such as WDR5 represent an ... contribute significantly in precision medicine for cancer patients. ...
(Date:6/23/2016)... -- The Prostate Cancer Foundation (PCF) is pleased to announce 24 new ... prostate cancer. Members of the Class of 2016 were selected from a pool ... Read More About the Class of 2016 PCF Young Investigators ... ... ...
(Date:6/23/2016)... ... June 23, 2016 , ... STACS DNA Inc., the sample tracking ... Arkansas State Crime Laboratory, has joined STACS DNA as a Field Application Specialist. ... Jocelyn Tremblay, President and COO of STACS DNA. “In further expanding our capacity as ...
(Date:6/23/2016)... -- Andrew D Zelenetz , ... Published recently in Oncology & ... Andrew D Zelenetz , discusses the fact ... placing an increasing burden on healthcare systems worldwide, ... the patents on many biologics expiring, interest in ...
Breaking Biology Technology:
(Date:6/16/2016)... , June 16, 2016 ... size is expected to reach USD 1.83 billion ... Grand View Research, Inc. Technological proliferation and increasing ... applications are expected to drive the market growth. ... , The development of advanced multimodal ...
(Date:6/7/2016)... 2016  Syngrafii Inc. and San Antonio Credit ... includes integrating Syngrafii,s patented LongPen™ eSignature "Wet" solution ... will result in greater convenience for SACU members ... maintaining existing document workflow and compliance requirements. ... Highlights: ...
(Date:6/2/2016)... 2, 2016 Perimeter Surveillance & ... Systems, Physical Infrastructure, Support & Other Service  ... offers comprehensive analysis of the global Border ... generate revenues of $17.98 billion in 2016. ... a leader in software and hardware technologies for advanced ...
Breaking Biology News(10 mins):