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Resources
Alliances
- Getting Your Drugs and Devices Approved at the FDA ... And Around the World!
Drug discovery computational modeling services, advanced analytics, and bioinformatics consulting services
Free Compliance reference library. Compliance books.
U.S. Government
- United States Food and Drug Administration
- Center for Drug Evaluation and Research (CDER)
- Center for Biologic Evaluation and Research (CBER)
- FDA warning letters and responses
- USDA - U.S. Department of Agriculture
- National Institutes of Health
Other Regulatory Agencies
- International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- Heads of Agencies (medicines authorities in the European Union)
- International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH)
- The European Agency for the Evaluation of Medicinal Products (EMEA)
- Medicines Controls Agency (MCA)
Pharmacopoeias
- British Pharmacopoeia (BP)
- European Pharmacopoeia (EP)
- Japanese Pharmacopoeia (JP)
- United States Pharmacopoeia (USP)
Associations
- American Association of Pharmaceutical Scientist (AAPS)
- American Chemical Society (ACS)
- American Institute of Chemical Engineers (AIChE)
- American Society of Consultant Pharmacists (ASCP)
- Drug Information Association (DIA)
- International Society of Pharmaceutical Engineers (ISPE).
- GMP Institute
- GAMP Guide for Validation of Automated Systems
- Medical Device Manufacturers Association (MDMA)
- Pharmaceutical Education & Research Institute (PERI)
- Pharmaceutical Research & Manufacturers of America (PhRMA)