Tablets & Capsules

TC0614SB

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60 June 2014 Tablets & Capsules Solid Dosage SourceBook Metrics Inc. is one of the most respected contract pharmaceutical research, development and manufacturing companies in the United States today. Started as an analytical laboratory in 1994, Metrics has evolved into a full-service provider of: • Quality pharmaceutical formulation development • First-time-in-man (FTIM) formulations • Clinical material manufacturing (CTM) for Phase I, II and III trials • Commercial manufacturing and • Analytical method development and validation services • Specialty technologies for controlled release, bioavailability enhancement and taste masking. Metrics proudly operates as a subsidiary of Mayne Pharma Group Limited, a publicly traded pharmaceutical company in Melbourne, Australia. Metrics has developed expertise in a number of key areas, including: • Formulation development. Our scientists offer expert recommendations on insoluble and unstable actives, potent and toxic actives, and small molecule delivery. • Potent and cytotoxic products. Our cGMP dedicated and segregated facility features custom-engineered total containment. With no open processes or PAPRs, and one-way material flow, containment is achieved at <=30 nanograms cpm. • Fast-track development. Metrics can meet accelerated timelines and deliver from NCE to first-time-in-man within six months. • Analytical methods development and validation. With 130+ analytical chemists on staff, Metrics' services include chromatography (LC and GC), dissolution (UV and LC finish), moisture, particle size, ion chromatography, AA/ICP, FTIR, titrations, particulate matter (HIAC), cleaning methods (LC and TOC), and LCMS. Metrics Inc. 1240 Sugg Pkwy. Greenville, NC 27834 Tel: 252 752 3800 FAX: 252 758 8522 Email: jeff@metricsinc.com Website: www.metricsinc.com Corporate Description Areas of Expertise Facilities and Additional Services Metrics Inc. • Clinical trial manufacturing. Metrics delivers materials for Phase I, II and III clinical trials. • Specialty Technologies. Metrics offers product development that leverages proprietary technologies in the areas of customized controlled release drug delivery; bioavailability enhancement for poorly water-soluble drugs; and improved palatability for liquid and solid presentations. Housing the latest development and analytical equipment within a state-of-the-art and cGMP 92,000-square-foot facility, Metrics also provides: • Commercial manufacturing • Stability storage and testing • Raw materials testing • Trace materials analysis • Microbiological testing Worldwide Regulatory Excellence Globally, Metrics provides a broad spectrum of services to support IND, NDA and ANDA submissions to the FDA and worldwide regulatory agencies for clients ranging in size from internationally renowned corporations to small virtual companies. Sourcebook_PBE-CCR 6/10/14 1:32 PM Page 60

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