Resources
Alliances
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)