The Investigational Medicinal Product (IMP) should be correctly labeled with the mandatory information required by the regulatory authorities; the label has to be permanently affixed to the container. In multinational trials this process can be more complex, as it is sometimes necessary to provide information in several languages (multi-lingual trials) as well as when several IMPs and/or medicinal products are being used.
Locally procured drugs are also subject to secondary labelling which should be done by a certified vendor who has an unrestricted pharmaceutical license. There may also be a need for extension labeling when the product has a very short shelf life and the “in time usage” becomes a critical issue. In such cases COREX labelling services can shorten the time required for drug release by providing a comprehensive solution that includes label design, printing and application services, all of which are performed under manufacturers’ guidelines.
All labeling procedures are performed by our trained and experienced staff at COREX warehouses in designated and specially equipped temperature-controlled areas.
corex process approach
- 1 LABEL DESIGN Creating study-specific label design.
- 2 LABEL APPROVAL Negotiating label application form with client/manufacturer.
- 3 PRINTING OF LABELS Specialized printing services.
- 4 LABEL APPLICATION Labelling in appropriate temperature-controlled zone.
- 5 RELEASE AND DOUBLE-VERIFICATION Double verification of all packages and release of the drug.