Mediantis Consult GmbH
Mediantis Consult GmbH offers consulting services with a focus on quality management and training for the pharmaceutical, biotech and medical device industries. The competences of the Ermatingen-based company include:
- Development of customised quality management systems and standards operating procedures (SOPs) according to GCP and EN ISO 13485 as well as implementation of existing quality management systems.
- Integration of existing quality management systems after company mergers/acquisitions
- Maintenance and improvement of existing quality management systems through analysis and assessment of existing processes with a focus on efficiency in compliance with legal requirements
- Analyses to uncover compliance gaps and process inadequacies as well as solution and implementation of CAPAs
- Development of customised and client-oriented training of quality management systems, including legal requirements and all quality management system documents.
- Training for the creation of efficient quality management systems
- Development of training concepts for education and training of clinical development staff
In addition, Mediantis Consult GmbH provides support in the area of clinical development through study management of clinical studies and medical writing.