Value Added Services
Based on a GMP Manufacturer’s Authorization with associated EU Certificate, FREJA performs inspection, re-labelling and secondary packaging for existing and new customers. Assembling kits consisting of specific information, pharmaceuticals and/or Medical Device/IVD products, is performed, i.e. handling of several brands of Covid-19 self-test kits.
These services also include storage, re-labelling and distribution of clinical supplies on behalf of several customers, as well as administration of free samples.
Clinical trials in Norway
Important clinical studies are performed world-wide to investigate safety and efficacy of new pharmaceuticals. As a small country, we are dependent on allocation of important clinical studies to Norway. This is a key to secure fast access to the best possible treatment methods and new generation of pharmaceuticals for Norwegian patients. Several international companies in FREJA’s portfolio have realized this, and actively promote and perform clinical studies in Norway on a regular basis.
[caption id="attachment_42215" align="alignright" width="300"] Examples re-labelling of clinical supplies.[/caption]
Compassionate Use
CU is a treatment option which allows active use of an unauthorised medicine. Under strict conditions products in the R&D phase may be made available to individual patients or groups of patients, who have a disease with no satisfactory therapies available. The compliance issues are similar to clinical trials.
FREJA’s Contribution
Clinical trial programs are extensive and challenging in nature. FREJA’s site Fjeldbo actively contributes in labelling, storage and distribution of products for clinical trials in Norway. Each project is handled individually based on a specific written contract with the client.
These products are handled in the Packaging Department by specially trained personnel who ensure that safe handling and full traceability is kept. FREJA offers GDP based express transport of clinical trial products with dedicated equipment, vans and drivers, to hospitals all over Norway. Product quality is secured with temperature loggers and necessary documentation for each transport. We keep full transaction history and perform safe destruction of obsolete material when needed.
FREJA actively supports clinical trials as a key to efficient healthcare services in Norway!