Useful Websites

U.S. GOVERNMENT AGENCIES

• Center for Biologics Evaluation and Research (CBER): Regulatory Guidance
• Center for Drug Evaluation and Research (CDER): Regulatory Guidance
• Center for Devices and Radiological Health (CDRH): Regulatory Guidance

INDUSTRY ORGANIZATIONS

• Advanced Medical Technology Association
• Biotechnology Industry Organization
• European Federation of Pharmaceutical Industries and Associations
• International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use
• International Federation of Pharmaceutical Manufacturers Associations
• Japan Pharmaceutical Manufacturers Association
• Pharmaceutical Research and Manufacturers of America
• Professional Organizations Drug Information Association
• European Society for Regulatory Affairs
• International Society for Pharmaceutical Engineering
• Regulatory Affairs Professional Society
• European Generic Medicines Association
• International Generic Pharmaceuticle Alliance

INFORMATION PROVIDERS

• BioSpace, Inc.
• Engle Publishing Partners
• Reg123.com Ltd.

DOCUMENT MANANGEMENT

• Documentum
• Eroom
• FileNET
• Hummingbird Ltd.
• Lotus Software from IBM (formerly Lotus Development Corporation)
• OpenText Corporation
• QUMAS

PRINTING SYSTEMS

• Digitec Business Systems, Inc.
• IKON Office Solutions
• Canon Corporation
• Xerox Corporation
• Publishing Outsource Services Covance
• PRA International
• Quintiles Transnational
• Regulatory/Clinical Consultants (RxCCI)
• CDC Solutions, Inc.
• Liquent, Inc.
• Hershey Technologies
• Image Solutions, Inc.

PRINING FACILITIES MANAGEMENT

• Digitec Business Systems, Inc.
• IKON Office Solutions
• Xerox Corporation

INTERNATIONAL GOVERNMENT AGENCIES

European Union:

• Agencies of Individual European Union Countries
• European Agency for the Evaluation of Medicinal Products

Central and Eastern Europe:

• Agencies of Individual CEE Countries

Australia

• Australia: Therapeutic Goods Administration

Asia Pacific:

• Japan Ministry of Health, Labor, and Welfare (formerly MHW)
• Agencies of Individual Asia Pacific Countries

Middle East:

• Agencies of Individual Middle East Countries

Africa:

• Agencies of Individual African Countries

Americas:

• Agencies of Individual Countries in the Americas
• Canada: Therapeutic Products Directorate

OTHER USEFUL LINKS

• US Code of Federal Regulations
• Orange Book
• National Institute of Health
• Center for Disease Control and Prevention (CDC)
• Medline
• European Regulatory News
• Pan European Regulatory Forum (PERF)
• Drug Information Association (DIA)
• Tarius Interactive - The Human Drug Regulations Database

CADREAC

• National Institute of Clinical Excellence Healthcare (NICE)
• Industry Online Resources
• World Health Organization (WHO)
• International Time Zones

PDF TOOL PRODUCTS

• Adobe Systems, Inc.
• Data Farm, Inc.
• Image Solutions, Inc.
• Infodata Systems, Inc.
• Doc Maestro

PRINTING SERVICES

• Digitec Business Systems, Inc.
• IKON Office Solutions
• XYAN