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Laboratory work according GLP

Development of analytical methods
Method validation according valid ICH-Guidelines
Galenical development and co-ordination of process and method validation, stabilities according ICH-guidelines
Stability studies
Quality tests
Market release analysis according to the registration

You benefit from our expertise and commitment

Patent search of API, manufacturing process, application and retention period
API search for quality and monograph along with an evaluation of the documentation
Evaluation of Drug Master Files
European search for dosage forms and filling sizes
Auditing of the API manufacturer according current GMP standard
Contract negotiations with API and finished product manufacturer