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.
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.