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David A. Dodd to Lead BioReliance Corporation
David A. Dodd has joined BioReliance as the Company's President, Chief
Executive Officer and Chairman of the Board, effective December 3, 2007.
From 2000 through 2006, Mr. Dodd served as President and CEO of
Serologicals Corporation, a publicly traded company that was sold to
Millipore Corporation in 2006 for $1.4 billion. Prior to that, from
1995 Mr. Dodd was President and CEO of Solvay Pharmaceuticals, Inc.
Click here to read the press release.
David L. Bellitt joins Bioreliance
David L. Bellitt has been named Vice President of Global Commercial Operations, Biologics. Mr. Bellitt will be responsible for all global commercialization activities, including sales, marketing and customer service. He will also serve as a member of the Corporate Operating Committee.
Click here to read the
press release.
BioReliance Corporation Launches iNet™ for Online Results Tracking of Biological Safety Tests
BioReliance is pleased to announce to US customers 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. Click here to read the press release.
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These pages provide access to regulatory guidance and other resources that are generally available from web sites operated and maintained by other organisations, as well as details of some of BioReliance's regulatory services.
BioReliance studies comply with the latest recommendations from the FDA, EMEA, ICH and WHO, the four main regulatory bodies for the biopharmaceutical industry.
In this section we have compiled a list of the most relevant guidelines from each Regulatory Authority, in order to keep you informed of the most up-to-date recommendations. Simply clicking on the document title will take you straight to the downloadable PDF file, where possible. Older regulations are not available to link to, but hard copies can be provided on request by BioReliance's Regulatory Affairs Department.
Click below, or on the navigation panel to the left, to go to our guidelines pages:
Many of the documents are in Portable Document Format (PDF) to maintain the appearance of the printed copy. In order to view any file with a PDF extension Adobe Acrobat Reader must be downloaded, installed, and able to run on your machine. The Acrobat Reader is free and is available for download from Adobe's Website.
These are the latest documents to be posted on our pages:
FDA
- ICH Draft Guidance on Q8 Pharmaceutical Development
- Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
- Draft Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
EMEA
- Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Quality Issues
- Report from the CHMP Gene Therapy Expert Group Meeting 14, 15 October 2005
- Guideline on Active Substance Master File Procedure
- Guideline on Requirements for Vaccine Antigen Master File (VAMF) Certification
- Concept Paper on the Development of a CHMP Guideline on Non-Clinical Testing for Inadvertent Germline Transmission of Gene Transfer Vectors
- ICH S8 Immunotoxicity studies for Human Pharmaceuticals – Note for Guidance on Immunotoxicity Studies for Human Pharmaceuticals (Step 2)
In addition, our regulatory department issues monthly updates on the latest guidelines and regulatory news from around the world. If you would like to receive these monthly updates by email, fill out the form to register.
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