Services
-
Identify, assess, and mitigate quality and operational risks
-
Ensure compliance with regulatory standards
-
Support throughout product life-cycle
Creation of a Contamination Control Strategy
-
Develop contamination control strategies including documentation and reports
-
Customize programs to minimize risk of contamination
-
Ensure product safety and integrity
-
Prepare for regulatory inspections and internal audits
-
Ensure compliance with regulations and industry standards
-
Provide support during and after regulatory inspections and internal audits
Regulatory Compliance and Quality System Implementation
-
Assess regulatory requirements
-
Establish compliant quality systems and processes
-
Ensure adherence to regulations and standards
Investigation and CAPA System Support
​​
-
Implement corrective and preventive actions (CAPA)
-
Improve quality systems and prevent recurrence
-
Assist in outsourcing specific functions or direct placement
-
Match staffing needs with skilled individuals or outsourcing partners