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		Introduction FDA EMEA ICH

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.

This page provides access to regulatory guidance and other resources that are generally available from web sites operated and maintained by other organisation.

The International Committee for Harmonisation (ICH)

These guidelines have been prepared through close co-operation between the European Union, Japan and the United States of America.

DOCUMENT TITLE* *Note: these links take you directly to the documents on the ICH or other authorities' web site. Please let us (info@bioreliance.com) know if you have problems accessing them.	DOCUMENT TYPE	DATE POSTED
Q7A; Good Manufacturing Practices for Active Pharmaceutical Ingredients.*	Note for Guidance	2000
Q6B; Specifications, Test and procedures for Biotechnological/Biological Products*	Note for Guidance	1999
Q5D; Derivation and Characterization of Cell substrates Used for Production of Biotechnological/Biological Products*	Note for Guidance	1997
S6; Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals*	Note for Guidance	1997
E8; General Considerations for Clinical Trials*	Note for Guidance	1997
S2B; Genotoxicity - A Standard Battery for Genotoxicity Testing of Pharmaceuticals*	Note for Guidance	1997
Q5A; Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin*	Note for Guidance	1997
Q5B; Quality of Biotechnological Products: Analysis of the Expression Construct in Cell Lines Used for the Production of r-DNA Derived Protein Products*	Note for Guidance	1996
Q5C; Quality of Biotechnological Products:Stability Testing of Biotechnological/Biological Products *	Note for Guidance	1996
E6; Guideline for Good Clinical Practice *	Note for Guidance	1996

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