Industry Associations
European Society of Regulatory Affairs European Federation of Pharmaceutical Industries and Associations Drug Information Association Regulatory Affairs Professional Society Pharmaceutical Research & Manufacturers of America Japan Pharmaceutical Manufacturers Association Society for Clinical Data Management
Standard Organizations Clinical Data Interchange Standards Consortium
DailyMed International Conference on Harmonization Common Technical Document/ electronic Common Technical Document (CTD/eCTD) Health Level 7 U.S. National Archives and Records Administration
Regulatory Authorities U.S. Food and Drug Administration (FDA) FDA Electronic Regulatory Submissions and Review FDA Electronic Submissions Gateway Center for Drug Evaluation and Research CDER Guidance Page CDER Electronic Submission Guidance, January 1999 CDER eCTD Page Office of Generic Drugs Center for Biologic Evaluation and Research European Agency for the Evaluation of Medicinal Products (EMEA) The Medicines Control Agency (MCA) Japanese Ministry of Health, Labor and Welfare (MHLW) Canadian Therapeutic Products Directorate EudraPortal National Institutes of Health
Product Information Management (PIM) United States Department of Health and Human Services World Health Organization
Validation Resources Society for Life Sciences Professionals Good Automated Manufacturing Practice (GAMP Online)
21 CFR Part 11 Resources 21CFR Part 11 resource website
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