Certifications
Authorizations
Danish Medicines Agency (DMA)
Eurofins Biopharma Product Testing Denmark A/S has an authorization from the Danish Medicines Agency to perform the following types of quality controls in accordance with good manufacturing practice (GMP) on medicinal products and investigational products for human use and medicinal products for veterinary use:
- Microbiological, non-sterility analyzes
- Chemical/Physical analyzes
Certificate of GMP Compliance, Human
Certificate of GMP Compliance, Veterinary
Certificate of GMP Compliance, IMP
FDA
Last inspection by FDA was June 2016. After the Mutual Recognition Agreement between FDA and the Danish Medicines Agency(DMA) in 2018, no new FDA inspection has been performed. However, Eurofins Biopharma Product Testing Denmark A/S continues to be registered with the FDA.
Registration certificate: Certificate of FDA registration
Environmental certification
Eurofins Pharma Scandinavia has following certifications concerning occupational health and safety as well as environmental:
Environmental Management System ISO 14001