Good Manufacturing Practice Audits
As a result of the implementation of European Directive 2001/20/EC, GMP requirements apply to investigational medicinal products (IMP) as well as products with a marketing authorisation.
ADAMAS Consulting has the expertise to provide a range of GMP services to ensure that clinical trials meet all of the necessary regulatory hurdles. These services include:
- Evaluation of GMP compliance in phase I units for the preparation and labelling of IMPs
- Audits of clinical trial supplies service providers
- Assessment of manufacturing sites for compliance with European GMP regulations
- Training of clinical staff in the requirements of GMP for IMP
- Consultancy advice on GMP requirements for specific IMPs
“I would like to thank you and your staff for your fine support and help throughout all stages of the audit process; it has been excellent”
J.M., Country Manager, International Biotech Company
An Introduction to Adamas
Patricia Fitzgerald, CEO of Adamas Consulting talking on the Adamas Consulting's reason for being.
Business in Europe
Markus Wallstein, Director GmbH
at Adamas Consulting talking on how Adamas Consulting's global network covers Europe.
Our Global Capability
Vaska Tone, V.P. North American Operations at Adamas Consulting talking on Adamas Consulting's Global Capability.
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