Quality
For Dompé, the concept of quality is more than just following a group of procedures and processes, it’s ingrained in our company culture. Quality is the cornerstone of our enterprise and is applied not only in the research, development, production and marketing stages but also in our staff, their training and the external environment in which our business operates.
Over a century of medical manufacturing expertise means we can produce the highest quality products that are safe and effective for patients.
Our operations comply with many regulations and standards including:
- ISO 13485 Medical devices. In addition, our medical devices department also complies with MDSAP (Medical Device Single Audit Program) International Regulations.
- Our L’Aquila production plant has authorizations from the regulatory authority Agenzia Nazionale Italiana del Farmaco – AIFA, from the Chinese regulatory agency and we are authorized for trade in the European and Russian market.
- We also follow applicable regulations from the US Food and Drug Administration (FDA), including: Good Laboratory Practices (GLP), Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP)