Manufacturing and packaging of IMPs has to be complemented by a comprehensive analytical service offering. Cooperating with an experienced company in this field, we are able to provide our clients with a reliable service offered as follows:
- Analytical method development and validation acc. to ICH-Guidelines (i.e. identity, assay, dissolution, moisture, particle size, etc.)
- Method transfer provided by the clients (if needed)
- Stability testing incl. storage of the stability samples in climate chambers
- Raw material / API testing
- Finished product (= Release) testing in order to enable the EU-Release
- Implementation of client specific requirements
The available equipment is "state-of-the-art".