CPS receives German pharma approval

Related tags Pharmacology

Clintrak Pharmaceutical Services (CPS) has announced that it has
been approved by the German Pharmaceutical Regulatory Authority for
secondary packaging, warehousing and distribution operations at its
manufacturing site in Freiburg, Germany.

The approval, which took place last month, means that manufacturing and import licenses are now in place and an EU release for Investigational Medicinal Products (IMP) to distribute to the sites will be done in due course.

In its first phase of operations, CPS will offer ambient and refrigerated storage and distribution services, including EU release of IMP, secondary packaging and labelling out of the initial 1,500 m² facility. Distribution will be provided for EU studies and Eastern European and Far East countries.

Freiburg is the European base for project management, including packing, storage, labelling and transport, as well as for taking back test substances used in clinical trials. In summer 2005, CPS took up operations in Freiburg with 10 to 12 employees, and since then enlarged its capacity in two stages with input from the fields of pharmacy, biology, chemistry and pharmatechnology.

The company will also be housing its European label reprinting capability from this site, which will allow it to provide reprints of all labels including its flagship GlobalPlyâ Booklet Labels. The facility is now available for client audits.

CPS provides services for the pharmaceutical and biotechnology industries and the company is active in the field of CTM (clinical trial material) packaging and logistics solutions.

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