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BioReliance Launches Next-Generation Genotoxicity Screening Service
BioReliance has contracted with Gentronix to offer their GreenScreen HC in vitro assay as a major part of BioReliance's portfolio of genotoxicity screening services. GreenScreen HC, in conjunction with Ames II assays, allows pharmaceutical companies to test for genotoxic potential earlier in the preclinical development process, using only a few milligrams of test compound as opposed to the gram quantities required by current ICH regulatory tests. Click here to read the press release.
Bioreliance Launches iNet, a Web-Based Tool for tracking Electronic Submissions of Biologics Tests
BioReliance is pleased to announce the release of iNet, a proprietary information technology system for submitting and tracking test article details via a controlled and secure Internet access from any location worldwide. Now you can view the status of current and past studies, keep informed of when testing will be completed, download reports, and allow your colleagues to view the status of your tests. iNet is currently available to US biologics testing customers upon request, but will be made available to a larger audience soon. Click here to read the press release.
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At BioReliance, our Quality
Systems group is actively involved in assuring compliance and implementing
high quality systems for all testing and production work.
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At BioReliance, our high profile and highly experienced
staff work to assure that the highest standards are maintained throughout
your project. The establishment and effective operation within a
testing facility of a program of Quality Assurance (QA) is a regulatory
requirement of GLP/GMP and is one of the principal means of assuring
that testing is conducted in accordance with regulatory requirements.
Additionally, the quality systems team is responsible for assuring
conformance with cGMP in our Manufacturing operations.
BioReliance's Quality Systems is responsible
for assuring compliance with worldwide GLP regulations (e.g. OECD,
FDA, EPA, EU) and applicable GMP regulations (e.g. FDA, EU, MHRA
‘Orange Guide’).
At BioReliance you can be assured of the highest quality of pro-active services:
- On-Going laboratory inspection program
- Audit of study data and final reports
- Batch approval for material produced by manufacturing group
- Document control
- Review of critical support documentation (SOPs, protocols, batch records, specifications)
- Archiving
- Host client and regulatory audits
- Perform environmental monitoring
- Assure quality of critical raw materials
- Perform inspections of suppliers and subcontractors
- Quality improvement and tracking / trending of quality key indicators
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