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Quality Certification

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Authorizations, GMP and GLP

Danish Medicines Agency (DMA)

Eurofins Biopharma Product Testing Denmark A/S has an authorisation 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 API, Human

Certificate of GMP Compliance API, Veterinary

Certificate of GMP Compliance, IMP

§39, Human & Veterinary

 

FDA

Last inspection by FDA was June 2016.

Registration certificate: Certificate of FDA registration

 

Furthermore, our Metals Competence Centre has a GLP approval from the Danish Medicines Agency:

Certificate of GLP Compliance

 

Approval to handle narcotic substances

Authorisation - Handling of euphoriant substances - Number 23681

 

Environmental certification

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

Occupational Health and Safety Management System OHSAS 18001 & Environmental Management System ISO 14001

Certified by DNV (Det Norske Veritas). The certificates are valid concerning activities related to sampling, testing and consulting.