Sharp Clinical Services
Type of organisation: Professional Services & Suppliers, Pharmaceuticals & Clinical Trials Services
Sharp Clinical Services are a leading provider of clinical supply chain services including product development and manufacture, packing, labeling, storage & distribution and QP audit and release services.
Our experienced project management and operational teams bring together years of experience in producing and managing your clinical supply chain across the Globe. All projects are compliant with the highest quality standards spanning Good Manufacturing Practices (cGMP), Good Distribution Practices, and all international regulatory requirements.
With Sharp Clinical Services’ experience of managing local and global clinical supply chains, access to the world markets just became easier from clinical production, labeling & distribution to comparator sourcing & EU Qualified Person (QP) audit and release services. We are big enough to deliver your global project while remaining small enough to care for your product like our own.
MHRA licensed facility conforming to the EU clinical trials directive, Sharp Clinical Services has the capability to:
• Manage the complete manufacturing and distribution needs for all trial phases
• Manage solid, semi-solid and large molecule clinical trials materials
• Import drug under MHRA wholesaler dealers’ license
• Support the preparation of the Investigational Medicinal Product Dossier
• QP services including supply chain audits and declaration, QP importation and batch certification and clinical batch release to the trial
• Manage controlled drugs for clinical activity under Home Office CD License
• Specialised distribution, retrieval and destruction of IMP and clinical material
• Audited depot network to support global distribution
Sharp’s sister site in Heerenveen now also delivers 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. In addition, our Rhymney and Heerenveen facilities have established a QP-to-QP agreement giving 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 Clinical Services news articles
15 August 2022
Sharp expands clinical services operations at its EU Heerenveen facility
Sharp expands its reach to China through partnership with ClinsChain
14 April 2020
Sharp Clinical Supports Development of Novel COVID-19 Vaccines and Treatments