Industry leading quality systems
and world-class regulatory expertise

Regulatory Guidance

These pages provide access to regulatory guidance and other resources that are generally available from web sites operated and maintained by other organizations, as well as details of some of BioReliance's regulatory services.

BioReliance studies comply with the latest recommendations from the FDA, EMEA, ICH, WHO, and MHLW the five main regulatory bodies for the biopharmaceutical industry.

In order to keep you informed of the most up-to-date recommendations, in this section we have compiled a list of the most relevant guidelines from each Regulatory Authority. Simply click on the document title and it 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:

FDA
EMEA
ICH
WHO
MHLW

If you have further questions, please click here to contact one of our regulatory experts.

*The Acrobat Reader is free and is available for download from Adobe's Website.