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 added labelling and secondary packaging services to support open and randomised clinical trials, to existing clinical storage and distribution capabilities. 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.
Sharp is a global leader in clinical supply chain services and pharmaceutical packaging. For more than 65 years, we’ve provided solutions to pharma and biotech clients from phase I trials through to commercial launch and lifecycle management. With facilities in the United States, United Kingdom, Belgium and the Netherlands and 30+ clinical depots globally, covering every region of the world, we are engineered to deliver.
Through our partnership with Berkshire Sterile Manufacturing we offer specialist isolator-based filling of vials, syringes, cartridges and containers, as well as lyophilization and terminal sterilization.
Our full complement of integrated services includes: research and development, clinical manufacturing, primary and secondary packaging of both investigational and commercial product, package design, serialization and aggregation, storage and distribution and clinical IRT. Sharp also offers Qualified Person (QP) services to meet the complex regulatory demands of the EU and UK.