GMP clinical batches
All the pharmaceutical formulations developed by Unither Développement Bordeaux are produced with a view to performance of the ICH stability studies required for a Clinical Trial Application.
After determination of the product's lifetime in stability studies, clinical batches can be produced in the same facility by the same personnel and using the same primary packaging.
After reviewing each batch's file, the head pharmacist signs a GMP certificate for the operations.
Thanks to a local partner with an international network, Unither provides packaging, clinical labelling and shipping for destinations worldwide.
COMPARATOR IMPORT
Thanks to its status as an AFSSAPS-accredited importer, Unither Développement Bordeaux is allowed to import comparators from non-European Union countries and perform batch release within Europe.