| Chemical
Synthesis Services (CSS) Created in 2000 from the merger of
two divisions of Galen Holdaings (QuChem and Syngal), CSS has
three sites in Northern Ireland - Belfast, Craigavon and Coleraine.
CSS offers synthetic chemistry research, development, cGMP production
and analytical services.
The site in Coleraine (40 miles from Belfast) is the headquarters
of the Analytical Services Division and provides bioanalytical
services tto the pharmaceutical industry, including method development,
validation and sample analysis. CSS Analytical Services has held
membership of the UK GLP programme since 1995, the most recent
inspection was in 2002. Studies can be performed to meet both
US (FDA and EPA) and OECD GLP requirements. CSS Analytical Services
is licensed for radio-labelled studies as well as cold material
analysis.
Bio-Kinetic
Clinical Applications Inc (BKCA), based in Springfield,
Missouri conducts Phase I - IV clinical trials. Studies are carried
out in a 132-bedded facility according to stringent FDA regulations.
The firm's highly developed information technology systems are
available in Belfast and Springfield, allowing client access to
standardised procedures at both sites.
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ACDM
EMWA
European
Society for Regulatory Affairs
BIRA
BMA
Pharmacos
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