Manufacturing

Clinical Trial Material

Clinical Trial Material

Bulk manufacturing

The experienced production team can produce investigational medicinal product for your clinical trial within in-house cleanrooms (class D). The produced bulk material can be either consecutively packaged and labelled for the clinical study or stored in a GMP storage until the demand arises.

Labelling of investigational medicinal products

We can guide your project when it comes to labelling requirements and possess in-house label printing capacity, sufficient to support the typical project demands. In case of complex designs or large volumes, we have established reliable and approved external suppliers to assist in this part of your project.

Secondary packaging for clinical trial

The production team finish the manufacturing for your clinical trial in a dedicated packaging room, which fulfills GMP requirements. Standard Operation Procedures, pre-approved manufacturing instructions and a training program with mandatory recurring training enables the team to handle packaging for open-label as well as blinded clinical trials. The flexibility is high in regards of types and quantities of packages and labels.

Distribution

In-house storage capacity within qualified and monitored areas enables Galenica to have full control of your produced investigational medicinal product. Once it’s time for distribution we guide you in selection of distribution agency and take care of correspondence with this agency as well as the consignee.

Our Business Model

Our Business Model

Galenica provide tailor-made business solutions and offers unique flexibility for our clients, with possibilities to either choose single parts of our service or a complete drug development program. Contact us here.

Business Model