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Eurofins Danmark >> Biopharma Services >> Certifications

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, sterility and non-sterility analyzes & Chemical/Physical analyzes.

Certificate of GMP Compliance, Human

Certificate of GMP Compliance, Veterinary

Certificate of GMP Compliance, IMP

Manufacturing license

Food and Drug Administration (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.

Certificate of FDA registration

Certificates

Det Norske Veritas (DNV)

Eurofins Pharma Scandinavia has following certifications concerning occupational health and safety as well as environmental.

Environmental Management System ISO 14001 & 45001