Quality Management
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Product Description
BioChem GmbH
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DE
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2015On CPHI since
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2Certificates
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100 - 249Employees
Company types
Categories
BioChem GmbH

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DE
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2015On CPHI since
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2Certificates
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100 - 249Employees
Company types
More Products from BioChem GmbH (6)
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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), rFC testing
• assay of antibiotics • effi... -
Product Analytics
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... -
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... -
Product Partner laboratories
BioChem Labor für biologische und chemische Analytik 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, ... -
Product Registration Support
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... -
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 (3)
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Brochure Manufacturer’s authorisation and QP service
BioChem Labor für biologische und chemische Analytik GmbH holds now, beside the GMP certification, also the manufacturer’s authorisation for
human medicinal products and investigational medicinal products acc. to § 13 AMG and
veterinary medicinal products acc. to § 28 TAMG and (EU) 2019/6
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