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| United Drug PLC
• United Drug PLC • United Drug Packaging |
Clinical Services Pharmaceutical, biotechs and contact research organizations rely on Sharp's Clinical Services. • Customer focused solutions. • Quality blistering, bottling and pouch packaging. • Study kit production, labeling and assembly. • Label, storage and distribution - domestic and international capabilities. • Package design and sample development. • In-house tooling production. • Returns and destruction. • Adaptive clinical trial support. • Expedited labeling operation (ELO). • Highest level of commitment to quality and service. Experience Sharp has more then 25 years experience in clinical packaging. Our strict compliance with industry procedures and audits provides our customers with the assurance that the program will be done properly and within specifications. • Experienced project management team. • Outstanding quality history with accurate documentation. • Flexible scheduling and quick turnaround. Capabilities Sharp has facilities available to handle your clinical pharmaceuticals such as controlled substances and a dedicated facility. The facility is DEA approved for Class II-V. All primary packaging is done in climate-monitored rooms with dedicated air-handling systems and humidity control. Quality Control • cGMP compliant. • Customer specified record retention. • FDA, EMEA, DEA, and foreign agency inspected. Package Design / Sampling / Tooling Award-winning package designers allow for better patient compliance. • Package design utilizing computerized systems available prior to production. • Child Resistant / Senior Friendly packaging. • In-house engineers produce tooling for the most accurate and efficient production of your package. Other Packaging Options • Small-scale bottling line specifically for low-volume orders. • Pouches and strip pouch packaging are other package options available for clinical trials. Our in-house printing and production capabilities enable Sharp Clinicals to produce kits and trays for a total clinical trial program. Study Kit Production and Assembly In-house printing and production of cards, trays and kits enable greater deadline and quality controls. The complete study kit can be produced, labeled and assembled at Sharp by experienced clinical packaging professionals in dedicated areas using process controls to assure accuracy. Blister and Carded-Blister Packaging Sharp has a reputation in the industry for outstanding blister and carded-blister packaging. • Semi-automated blister equipment can rapidly produce cost-effective blister packages of the highest quality. • State-of-the-industry thermoforming and coldforming blister equipment for large-scale packaging demands. • Colored-coded proofing system. • Child-resistant opening features are available on both blister and card-blister formats. Storage • Secured and dedicated storage of materials in climate controlled warehouses. • Cold-chain and freezer storage with monitored and alarmed temperature controls. • Vault storage areas for DEA controlled substances Class II - V available. Distribution Sharp supports global distributions to clinical study sites and / or depots. Returns and Destruction Sharp Clinicals provides a dedicated return storage area and handles accountability and reconciliation according to the client's instructions with 100%. For destruction of materials, Sharp has a contract with a waste management company certified by the Environmental Protection Agency (EPA) and the Department of Environmental Control (DEC). The Benefits of Sharp Clinical Services Trust your clinical trials to the provider who can meet or exceed your expectations. Some benefits in working with Sharp as your clinical trials contract service provider include: • Packaging expertise without capital expenditure. • Quick response to meet tight deadlines. • In-house printing and production of cards, kits, trays and cartons. • In-house tooling production and engineering services for expedient service. • Warehousing, distribution and destruction for packaging. • cGMP standards practiced and adhered to. • True team relationships and partnerships. • Ability to support virtual to large pharma and biotech companies. Sharp has the experience, capabilities and quality systems to handle your complete clinical material services needs quickly and with exceptional service. Christine Wenner Clinical Operations Director christine.wenner@sharpcorporation.com May Wattie Singh Clinical Sales Manager Cell: 443.876.6003 may.singh@sharpcorporation.com |