Quality Culture
Quality – Embedded in
All We Do
When you partner with us, you will observe our quality mindset from the outset. To deliver safe and effective manufacturing processes, our ways of working are designed such that quality is embedded from initial development stages throughout.
We proactively promote a culture of continuous improvement, supporting our people to engage in industry groups that define best practices and influence regulations, including BioPhorum and ISPE. This quality culture permeates the organization, allowing you to trust in all we do and empowering our staff to shape our business.
Quality Management Systems
A global network of quality expertise means that we have the flexibility and expertise to both transition from Phase I to commercial and to transfer in an existing process.
Our mature electronic Quality Management System (eQMS) defines, monitors and manages real-time quality metrics to ensure processes and ways of working are continually improved, ensuring operational excellence.
You can trust us to be transparent, as we prioritize reliably and safely delivering your product. We understand that each molecule, like every customer, has unique needs, so we work with you to agree the right and most efficient path forward to ensure approval of the product.
Our eQMS includes:
- Controlled document systems
- Deviation/CAPA management
- Change control management
- OOS
- Training
- Vendor Qualification
- Internal Audits
- Data Review
- Material Handling
We partner with you on:
- Quality Agreement
- Master Batch Records
- Intermediate and Drug Substance Item Specifications
- Client-Specific Test Methods
- Deviations and CAPAs related to your process and product
- Validation Protocols and Summary Reports
Facilities
View all of our facilities.