Issue link: https://www.e-digitaleditions.com/i/446555
Tablets & Capsules Janaury 2015 63 Xcelience ® offers a suite of services that includes global clinical supplies packaging and logistics for all of our clients' clinical trial needs. We offer complete primary and secondary packaging services in support of Phase I-III clinical projects, as well as worldwide distribution and storage under climate- controlled conditions, clinical retains, returns, accountability, reconciliation and destruction. In 2013, Xcelience introduced its first international expansion by opening a facility in Burton-on-Trent, near Birmingham, UK. This facility provides a central distribution hub for labeling and distribution throughout Europe and is the first step in a multi- stage plan to provide our clients with global clinical packaging and distribution services. In June 2014, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) fully inspected the facility. The facility offers storage, secondary packaging, labeling and clinical trial distribution operations. Other capabilities include qualified person (QP) release and lab services. Xcelience is the first CDMO with revenue under $1 billion to make this type of move to service clients internationally. Xcelience's Global Clinical Supplies Capabilities include: • Bottling • Blister packaging (thermoform, cold form) • Labeling for a multiple variety of primary containers • Kit assembly including ancillary supplies • Blister card/wallet sealing • Comparator sourcing • Cold room & clinical labeling • Point of distribution (POD) labeling and distribution • Global distribution & clinical supply storage/temperature cGMP controlled warehousing (- 20°C, 2°C- 8°C and 20°C) • Controlled drug warehousing for DEA II-V • Retains storage & testing, returns, reconciliations & destruction In addition to offering global clinical supplies packaging and logistics, Xcelience also offers a suite of services that include preformulation, analytical services, formulation development, GMP manufacturing and small-scale commercial manufacturing. Our goal is to provide superior drug product development and global clinical supplies solutions to our pharmaceutical and biotech customers in support of their global clinical needs. As the premier trusted CDMO and Clinical Supplies Solutions (CSS) global partner, we are steadfast in our commitment to providing sound solutions. We take a personal approach to each customer relationship and pride ourselves in our ability to deliver superior clinical trial supplies, when and where our clients need them. Xcelience has 3 additional facilities in Tampa, FL. The West Laurel Street headquarters houses preformulation, analytical services, formulation development and GMP manufacturing. The West Grace Street facility is dedicated to primary and secondary packaging and global clinical supplies distribution and logistical services. The Johns Road facility is used for distribution, returns processing, retain storage and destruction of clinical trial supplies. In 2015, Xcelience will be expanding further with new locations and enhanced service offerings. Corporate Capabilities 5415 West Laurel St. Tampa, FL 33607 Tel: 813 286 0404 Email: info@xcelience.com www.xcelience.com