Below are some links that we hope you will find useful.
Europe
European Medicines Agency (EMEA)
"Eudralex" Rules Governing Medicinal Products In The EU
Quality Working Party Guidelines - for EU Marketing Authorisation Applications
EMEA Inspections Homepage
EU Inspectorates - What's New
GMP Sector of the EMEA Site
USA
Food and Drug Administration (FDA) Home Page
FDA - Centre for Biologics Evaluation and Research
FDA - Centre for Drug Evaluation and Research FDA - Codes of Federal Regulations
FDA - Inspection References: Index
FDA - Inspection Guides
FDA - Guidance Documents: Index
FDA - Warning Letters - General Searches
WHO - World Health Organisation
WHO
Pharmaceutical Inspection Cooperation Scheme
PICS
Van Kuppeveld Farma Consultancy
Paterswoldseweg 8299728 BM Groningen
T: +31 (0)6-250 81 211F: +31 (0)50 - 589 07 39
