apceth Biopharma’s Quality Management (QM) ensures that full regulatory compliance and the highest quality and safety standards are at the center of every client project and form an integral part of the final process and product.
Our quality management experts provide comprehensive QM services in line with international ICH guidelines, European ATMP Regulation (EC) No.1394/2007 and all applicable national laws (e.g. German Medicine Act).
- Document management
- Qualification and validation
- Material and vendor qualifications
- Quality risk management
- Deviations, CAPA, change control
- Contact and collaboration with the regulatory agencies
- Audits and inspections
- Personnel training and training status management
- Compliance status management