At Eden Biodesign, we comply with global regulatory requirements and best industry practice to ensure the right outcome, whether it is for process development, analytical testing or cGMP manufacture of biologics.
Our systems are flexible enough to support cost-effective product development and commercialisation, yet robust enough to ensure that the multi-product facility maintains regulatory-compliant control over all projects.
Quality Assurance is central to all our operations, driving home our programme for continual improvement.
Our activities include:
- Facility, supplier and 3rd party audits
- Document control
- Change control
- Batch record compilation and review
- QP release