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WebSite Links
Thank you for visiting our web site! Listed here are the primary web sites that you might need.
Agencies (general)
FDA
Food and Drug Administration (FDA).
MCA
Medicines Controls Agency (MCA).
EMEA
European Agency for the Evaluation of Medicinal Product.
Clinical Research
FDA
FDA regulations relating to Good Clinical Practice and clinical trials.
ICH
ICH GCP
EUDRA
EU clinical trial directive 2001/20/EC
EMEA
EU GCP directive
ICR
Institute of Clinical Research
Computer Related
GAMP
Good Automated Manufacturing Practice, GAMP.
Lab Compliance
Labcompliance is private organization that provides the regulated Bio/Pharmaceutical industry with information on how to improve quality and to comply with FDA and other regulations.
CMMI
Capability Maturity Model® Integration (CMMI) is a process improvement approach that provides organizations with the essential elements of effective processes.
COBIT
COBIT is an IT governance framework and supporting toolset that allows managers to bridge the gap between control requirements, technical issues and business risks. Go to the CobiT pages on the ISACA site.
Members of our GxP network
PCS
PCS provide training and consultancy services to the pharmaceutical, medical devices and related health care industries.
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