Quality & Project Management
Abzena has an established System of Quality to meet the quality and regulatory requirements of products manufactured for Phase I and II clinical trials meeting US and EU regulatory standards.
Abzena’s Quality Systems Include:
- Acquisition and Control of Materials
- Control of Facilities and Equipment
- Process Performance Monitoring
- Product Quality Monitoring
- Document Management
- Discrepancy Management
- Corrective Action and Preventive Action System
- Change Management System
- Quality Audits
- Management Review of Process Performance and Product Quality
Abzena’s manufacturing solutions are tailored for each project to ensure that the objectives are met or exceeded. Experienced project teams are assigned to each study focusing on progressing projects through to results. Abzena’s clients widely regard us as professional and attentive partners who deliver quality results.
To get more information, a quote or to schedule a teleconference please contact us.