The quality services provided to third parties and performed in our quality control laboratory and by the regulatory team consists of the below listed activities:
Quality control of API’s and excipients
preformed to third party partners from the EU.
Analytical method transfers and batch retest of products
with valid marketing authorisation in EU countries but produced by contract manufacturers outside the EU.
Batch Release on EU markets
of products with valid marketing authorisation in EU countries but produced by contract manufacturers outside the EU.
Stability testing according to ICH guidelines
(accelerated, intermediate, long term, bulk stability, holding time, photostability, in use, open pot, thermal cycling and zone IVb)
Complete validation and documentation
of all methods and procedures relevant for drug registration according to all EU-, ICH- and any country specific requirements identified by the clients.