Drug Regulatory Affairs and Compliance for Human Drug Products


Introduction: This site attempts to provide current sources of drug law, regulations, guidelines and other information issued by the US FDA via the internet relevant to the registration of applications and CGMP compliance for human drug products. assembled by Bruce G. Berger

Table of Contents

The best single source for concise general information about the regulatory environment of the FDA can be found at its Small Business site. More detailed information can be found at the references below. The information provided below is part of what can be considered the "regulatory hierarchy pyramid" which defines the regulatory environment.

Information is grouped into several major categories:

[Regulatory and Compliance] [Scientific]

Regulatory and Compliance Information


Contacting Bruce G. Berger

e-mail to Bruce G. Berger

CMC Applications
Bruce G. Berger
Oldsmar, FL 34677
Phone 727-786-3954
all rights reserved: 1997