As each partner is unique, we approach each project to fulfil their specific requirements and tailor our services accordingly.
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 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, process modeling and optimized experimental approaches to maximize transfer effectiveness
- We work to ensure transferred processes are robust and thorough through 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, DEA controlled site, packaging facilities for U.S. and E.U.
Access to strategic solutions for your product:
- Proven Life Cycle Management strategies
- Full CMC package capabilities for regulatory registration
Opportunity to examine tax options:
- Athlone, Ireland facility is located in a Low Tax Jurisdiction (LTJ)
Process optimization post-launch:
- Small scale, reduced API cost, material changes, additional strengths.
For a list of our Partners please click here
