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Donna Klein joins Bioreliance
Donna Klein has been named Vice President,
Human Resources, responsible for the human resource functions for all the company's locations including the United States,
United Kingdom and Asia.
Click here to read the
press release.
Darryl L. Goss joins Bioreliance
Darryl L. Goss has been appointed Vice
President, Toxicology/Laboratory Animal Diagnostic Services (LADS), a new executive position created to lead this newly
formed Business Unit.
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- ICH Draft Guidance on Q8 Pharmaceutical Development
- Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
- Draft Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection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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