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Our partners are unique As each of our partners is unique, we tailor our services according to their specific project requirements. Speed to Market: – Proven efficiency with on-site technical, development and manufacturing services and registration support to provide a fast efficient service – Capacity to design, build, commission, qualify and commercialize any solid oral process on-site Compliant, Reliable and Cost Efficient Supplier: – Excellent compliance record in the U.S. and Europe with experienced and motivated staff – Flexible infrastructure and efficient operations with mature Lean 6 Sigma/ Operational Excellence programs Effectiveness of Transfer: – We leverage through process and product understanding, honed risk assessment (RA), process modelling and optimized experimental approaches, to maximize transfer effectiveness – We work to ensure transferred processes are robust and capable. – Process documentation, QA systems, calibration and maintenance activities that are targeted towards key process variables/steps (i.e. waste elimination and error proofing by design) Dedicated Customer Service: – We believe in the importance of open communication – A dedicated project management resource will keep you informed at all stages in the project/commercial supply arrangement Access to Full Capabilities of Our Sites: – Capacity of 2.5 billion solid dosage units, process and analytical equipment, Drug Enforcement Administration (DEA) controlled site, packaging facilities for U.S. and EU Opportunity to Examine Tax Options: – Facility located in a Low Tax Jurisdiction (LTJ) Process Optimization Post-Launch: – Small scale, reduced Active Pharmaceutical Ingredients (API) cost, material changes, additional strengths.
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