Stella
Technical professional services firm providing QA, validation, regulatory support, manufacturing troubleshooting, and analytical/QC laboratory support for life sciences and manufacturing clients. Operates regionally in Northern New Jersey, Research Triangle (NC), and Eastern Nebraska.
Industries
Nr. of Employees
small (1-50)
Stella
Jersey City, New Jersey, United States, North America
Services
On-demand investigations and quality engineering services to identify root causes and implement corrective actions.
Validation services for computerized systems and automated equipment, including CSV protocols and execution.
Execution of equipment installation and operational qualification and cleaning validation studies.
Product assessment services to identify compliance gaps and perform remediation activities.
Support for product technology transfers and process validation to enable consistent manufacturing.
Analytical testing and QC laboratory assistance to support product release and investigations.
On-demand investigations and quality engineering services to identify root causes and implement corrective actions.
Validation services for computerized systems and automated equipment, including CSV protocols and execution.
Execution of equipment installation and operational qualification and cleaning validation studies.
Product assessment services to identify compliance gaps and perform remediation activities.
Support for product technology transfers and process validation to enable consistent manufacturing.
Analytical testing and QC laboratory assistance to support product release and investigations.
Expertise Areas
- Quality assurance and investigations
- Computer system validation (CSV)
- Process and cleaning validation
- Technology transfer and scale-up
Key Technologies
- Computer system validation
- Equipment IQ/OQ protocols
- Cleaning validation methodologies
- Process validation methods