Sharp has received Investigational Medicinal Product (IMP) and Wholesale Distribution Authorization (WDA) licensing approvals to support clinical activities from its facility in Heerenveen, Netherlands.
Sharp can now provide EU QP services and distribute IMPs to clinical sites across the continent from a European site.
The existing facility in Heerenveen, which underwent a complete renovation in 2018, will now accommodate clinical storage and distribution, allowing Sharp to co-locate commercial packaging and clinical services at this location.
This development will see Sharp offer QP release, dedicated temperature-controlled warehousing and shipping from its European-based facility, whilst also providing a regulatory solution for its customers.
“These approvals mark another significant milestone in the growth of our Clinical Services footprint and represent an excellent opportunity for our new and existing clients to access Europe,” Frank Lis, president of Sharp Clinical Services, said. “The ability to provide clinical support services at our Heerenveen facility has strengthened our position within the global clinical market.”
Sharp Clinical clients will continue to be supported from the company’s Rhymney location but now have the option of releasing and distributing their products from within the EU area at the Heerenveen facility.
The Heerenveen facility will be ready to receive clinical material in October 2019. The approval follows Sharp’s recent successful and Healthcare Product Regulatory Agency (MHRA) inspection for its Clinical Services Centre of Excellence facility in Rhymney, Wales.