Registration Support

Registration Support
Product Description

BioChem GmbH offers a wide range of services which includes registration support. Features: IMPD investigational medicinal product dossier, module 3: Quality, ASMF active substance master file, QOS quality overall summaries, QES quality expert statements, application for modification, extension, responding to deficiency letters.

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BioChem GmbH

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

BioChem GmbH

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

More Products from BioChem GmbH (6)

  • Microbiology

    Product Microbiology

    Excerpt from the range of services offered by our microbiological department: • microbial contamination testing (bioburden) • identification of microorganisms • sterility testing • biological indicator testing • bacterial endotoxin testing (LAL) • assay of antibiotics • efficacy of preserva...
  • Analysis

    Product Analysis

    Excerpt from the range of services offered by our analytical department: • physico-chemical testing • chromatography • spectroscopy/spectrometry • determination of TOC/TNb (water analysis/cleaning validation) • particle measurement
    • elemental analysis
    • dissolution testing
    • pho...
  • Bioanalytics/Molecular Biology

    Product Bioanalytics/Molecular Biology

    Excerpt from the range of services offered by our bioanalytical/molecular biological department:

    • determination of mycoplasma • biological contamination testing • determination of content and identity of nucleic acids • determination of biological activity
    • protein/antibo...
  • Quality Management

    Product Quality Management

    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: • Ma...
  • Partner laboratories

    Product Partner laboratories

    BioChem GmbH offers a wide range of services which includes partner laboratories. Features: Identification of impurities, extractables / leachables, test for pyrogens in rabbits according to Ph Eur.. 2.6.8 / USP, test for abnormal toxicity Ph. Eur. 2.6.9 / USP, special techniques, XRPD, electron, NMR, LC-M...
  • Sample transport

    Product Sample transport

    BioChem GmbH offers a wide range of services which includes sample transport. Features: Pick-up of samples directly from the customer, transport under qualified conditions, eg 2-8 ° C. Contact us for more information.

BioChem GmbH resources (6)