Laboratory Services

Product Description

Laboratory Services
Our 30 years of experience and our continual quest for improvement ensure we deliver analytical services of the highest level for active ingredients, excipients, medicinal products and drug-​related products. In addition to developing and validating analytical methods, batch-​release analysis, stability testing and structure determination of unknown substances, our core expertise also include risk-​based and solution-​oriented customer consultation.

More than 45 employees work in our analytical labs, supported by lean management tools, to specifically and efficiently meet the requirements of our clients.HWI is GMP- and FDA-​certified and holds a manufacturing authorisation for the release of clinical and market batches.

Core competencies
Quality control for APIs, intermediates, excipients and drug products as well as medical devices and drug-device combination products

  • Small molecules
  • Peptides
  • Proteins
  • Narcotics
  • High-potent APIs up to OEB 4
  • Herbals
Development & validation
  • For assay, purity and drug release
  • Chromatographic methods
  • Titration testing procedures

Routine testing
  • Batch release testing / quality control
  • Stability studies and stability storage facilities (25⁰C/60%, 30⁰C/65%, 30⁰C/75%, 40⁰C/75%, 2-8⁰C)
  • Photostability studies
Purity testing – trace analysis

  • Extractables/leachables studies
  • Potentially genotoxic impurities
  • Cleaning validation studies
  • Elemental impurities
  • Residual solvents
  • Troubleshooting & root cause analysis: impurities from production processes
  • Structure elucidation using mass spectroscopy and NMR
  • Modern analytical physical methods: SEM-EDX, Raman, XMT

HWI pharma services GmbH

  • DE
  • 2015
    On CPHI since
  • 2
    Certificates
  • 100 - 249
    Employees
Company types
Consultancy
Contract Service
Manufacturer/Innovator

HWI pharma services GmbH

  • DE
  • 2015
    On CPHI since
  • 2
    Certificates
  • 100 - 249
    Employees
Company types
Consultancy
Contract Service
Manufacturer/Innovator

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HWI pharma services GmbH resources (1)

  • Brochure HWI group - services for phama & biotech

    The HWI group offers a broad range of individual and specialised pharmaceutical services for the pharma and biotech sector, particularly for active ingredients and medicinal products. Benefit from our long-​standing experience in laboratory services, vigilance and quality services, drug development as well as regulatory affairs services.