Quality Management

Quality Management
Product Description

If you trust in BioChem, you are in the best of hands, because you work together with a quality-tested full service provider. Our high-quality standards are also regularly confirmed by the authorities during inspections.


BioChem is your quality approved full-service provider:

  • Manufacturer’s Authorisation for:
    human medicinal products/human investigational med. products acc. to § 13 AMG
    veterinary medicinal products acc. to § 28 TAMG and (EU) 2019/6
  • Own QP (Qualified Person) acc. to § 15 AMG
  • GMP-certified (last inspection: 03/2022)
  • FDA-registered and repeatedly successfully inspected (last inspection: 11/2017)
  • GLP-certified (last inspection: 04/2021)
  • approx. 30-40 customer-based audits per year
  • regular self-inspections

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BioChem GmbH

  • DE
  • 2015
    On CPHI since
  • 2
    Certificates
  • 100 - 249
    Employees
Company types
Contract Service
View company profile
Categories
more categories Show less

BioChem GmbH

  • DE
  • 2015
    On CPHI since
  • 2
    Certificates
  • 100 - 249
    Employees
Company types
Contract Service
View company profile

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BioChem GmbH resources (6)