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Contract Pharma Service Brochure

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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