Sharp expands clinical services operations at its EU Heerenveen facility

Sharp a global leader in contract packaging and clinical supply services, has expanded its clinical services offering at its Heerenveen facility in the Netherlands.

The site has complemented existing clinical storage and distribution capabilities by adding labelling and secondary packaging services to support open and randomised clinical trials. The first packaging and labeling operations have already been completed.

Sharp can now deliver a full suite of clinical services from the facility including, secondary packaging under 15-25°C, 2-8°C and on dry ice, storage and distribution up to and including -80°C as well as QP release for clinical trial materials.

The site can also offer regulatory solutions for its customers to release and distribute products within Europe, including Importer of Record services to the EU. 

On these expanded operations, Vesna Bondzulic, site manager at Sharp Heerenveen said: “This development marks a significant milestone in the growth of Sharp’s European clinical capabilities and complements the offerings available across our facility network in the EU, the UK and the USA.

“We’re excited about the opportunities this expansion will bring, allowing us to meet our clients’ demands for specialised secondary packaging and strengthening our position in the European market”

Heerenveen received Investigational Medicinal Product (IMP) and Wholesale Distribution Authorisation (WDA) licensing approvals in 2018, co-locating commercial packaging and clinical services at the facility.

A QP-to-QP agreement between Sharp UK and EU facilities gives Sharp the infrastructure necessary to transfer regulatory and support information allowing delivery of audits, QP declarations and QP IMP batch release services between the UK and the EU.