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    • Quality management
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    HWI group

    The HWI group is an innovative and independent partner of the pharma and biotech industries. Today we offer our services for active ingredients, medicinal products and associated products at our sites in Rülzheim and Frankfurt (HWI pharma services GmbH) and Appenweier (HWI development GmbH).

    HWI group

    The HWI group provides a wide range of individual and specialised pharmaceutical services for the pharma and biotech industries, in particular for active ingredients and medicinal products.

    Quality management

    Quality management is a critical and strategic factor for us. We meet all the requirements stipulated in quality-control and quality-assurance regulations. Find out here what we do to achieve the highest possible quality and how we live by these requirements.

    Contacts

    You can find an overview of our contacts in different divisions here. However you can also simply ask our main office and we will connect you with the right person.

    Media centre

    Videos and live streams of HWI group are available in our media centre. Discover movies providing insights into the company and our services.

    News

    Companies that grow and develop have people who work towards this on a daily basis. A lot happens at the point where people and work mix – and that’s what we want to report. The most important news can be found here.

    Funding

    HWI group projects supported by funding programs.

  • Services
    • Laboratory
      • Laboratory services
      • Development and validation
      • Impurities
      • Quality control
      • Reference standards
      • Product range reference standards

      Laboratory

      We are your partner for pharmaceutical analysis and quality control. Our 30 years of experience mean we offer the highest quality analytical services for active ingredients, excipients, medicinal products and drug-related products in our GMP- and FDA-certified laboratories.

      Laboratory services

      We are your partner for pharmaceutical analysis and quality control. Our 30 years of experience mean we offer the highest quality analytical services for active ingredients, excipients, medicinal products and drug-related products in our GMP- and FDA-certified laboratories.

      Development and validation

      We develop and validate test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, ready-to-use products and medical devices in accordance with international regulatory requirements and the latest scientific and technical knowledge.

      Impurities

      In addition to method development and validation to determine synthesis by-products and degradation products, we are specialised in the field of impurity trace analysis.

      Quality control

      In our GMP- and FDA-certified laboratory we conduct analytical testing as part of batch release for active ingredients, medicinal products and drug-related medical devices. We can undertake all your stability testing: storage, analytical testing and stability report as part of ICH studies and follow-up studies.

      Reference standards

      We have been involved in the preparation, purification and qualification of pharmaceutical reference standards for 30 years. This knowledge and experience makes us the ideal partner for your reference standards needs.

      Product range

      Our reference standard product range covers a wide range of qualified primary and working standards at a cost-effective price–performance ratio.

    • Vigilance & Quality
      • Vigilance and quality services
      • Pharmacovigilance
      • Quality management/batch release

      Vigilance & Quality

      Our interdisciplinary team offers all services relating to pharmacovigilance, quality management and batch release.

      Vigilance and quality services

      Our interdisciplinary team offers all services relating to pharmacovigilance, quality management and batch release.

      Pharmacovigilance

      Based on good pharmacovigilance practice (GVP) recommendations we provide comprehensive and individual support for all pharmacovigilance matters.

      Quality management/batch release

      We provide advice on how to meet quality-management requirements in accordance with legislation and hold our own manufacturing authorisation for the release of market and clinical batches of medicinal products.

    • Development
      • Drug development
      • Pharmaceutical technologies
      • Product life-cycle management
      • Certification
      • 360°Cleanroom

      Development

      The active ingredient is at the heart of our risk-based formulation development. Its properties have a critical influence on the quality of the product. In our ultra-modern clean rooms we can also work with highly potent active ingredients. By using statistical design of experiment (DoE) we offer an efficient pharmaceutical development that completely fulfils the requirements of quality by design.

      Drug development

      The active ingredient is at the heart of our risk-based formulation development. Its properties have a critical influence on the quality of the product. In our ultra-modern clean rooms we can also work with highly potent active ingredients. By using statistical design of experiment (DoE) we offer an efficient pharmaceutical development that completely fulfils the requirements of quality by design.

      Pharmaceutical technologies

      New active ingredients are often poorly soluble. Innovative technologies are needed to meet these requirements. We offer these, with nanotechnology being a particular focus. You can also expect us to provide conventional production processes.

      Product life-cycle management

      Market changes and constantly changing regulatory requirements place manufacturers under permanent pressure to adapt or optimise medicinal products that are already being marketed. We provide you with support to successfully implement change management.

      Certification

      Our laboratories are GMP-certified and we hold a manufacturing authorisation in accordance with section 13 of the German Drug Law (AMG) on the manufacture and release of clinical test samples and small market batches for topical and oral solid and liquid medicinal products.

       

      360°Clearoom

      Take a look at our heart of drug development. State of the art technological equipment enables the processing of high potent active ingredients.

    • Regulatory Affairs
      • Regulatory services
      • Medicinal products
      • Biotech products
      • Medical devices
      • Combination products
      • In vitro diagnostics

      Regulatory Affairs

      We support you in development, approval and lifecycle management projects for medicinal products as well as in the classification, evaluation and certification of your medical devices, in-vitro diagnostics and combination products.

      Regulatory services

      We support you in development, approval and lifecycle management projects for medicinal products as well as in the classification, evaluation and certification of your medical devices, in-vitro diagnostics and combination products.

      Medicinal products

      The pharmaceutical quality, efficacy and safety must be guaranteed to obtain a drug marketing authorisation. We know the specific requirements and can help you make your projects a success.

      Combination products

      Products that include a medicinal product and medical device portion present a particular challenge in the EU. The requirements of the corresponding regulations must be met, which makes the documentation and evaluation process extremely complex. We will help you!

      Medical devices

      Your challenge as a manufacturer is the regulatory classification of your product. Is it a medicinal product or medical device? You need to know this at an early stage of development as both product categories are subject to different legal frameworks in Europe.

      Biotech products

      Do you want to use your biotech product as a biopharmaceutical or medical device?

      With our teams in Regulatory Affairs, Development, Analytics and Quality, we will accompany you through all stages up to the successful authorisation of your biotech product.

      In vitro diagnostics

      In vitro diagnostics represent an interesting interface between science and medicine and form the basis for successful diagnostics and therapy.

      We support you in converting your products to meet IVDR requirements.

    Services

    The HWI group provides a wide range of individual and specialised pharmaceutical services for the pharma & biotech industries, in particular for active ingredients and medicinal products.

  • Careers
    • HWI group team
    • Vacancies
    • Career and family

    Careers

    The work, expertise and development of each individual member of staff determines the quality of our services and, in turn, our success.

    Become part of the success story.

    HWI group team

    The work, expertise, and development of each individual member of staff determines the quality of our services and therefore our success.

    However, what characterises us and leads to our success is our team – get to know us and discover what it means to be part of the HWI team.

    Vacancies

    Our owner-run, medium-sized company offers a wide range of possibilities and long-term prospects in a fantastic team – do you want to be part of the success story? Then we look forward to getting to know you!

    Training/work placements

    We support our customers in the pharmaceutical industry in many exciting projects on their future path – find out what options we can offer to support you in your professional future.

    Career and family

    We want our employees to be able to easily coordinate their private and professional lives. As part of our personnel policy aimed at the different phases of life we are continuously working on this and are certified for doing so – you can find further details here.

     

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Skip navigation
  • Company
    • HWI group
    • Quality management
    • Contacts
    • Media centre
    • News
    • Funding
  • Services
    • Laboratory
      • Laboratory services
      • Development and validation
      • Impurities
      • Quality control
      • Reference standards
      • Product range reference standards
    • Vigilance & Quality
      • Vigilance and quality services
      • Pharmacovigilance
      • Quality management/batch release
    • Development
      • Drug development
      • Pharmaceutical technologies
      • Product life-cycle management
      • Certification
      • 360°Cleanroom
    • Regulatory Affairs
      • Regulatory services
      • Medicinal products
      • Biotech products
      • Medical devices
      • Combination products
      • In vitro diagnostics
  • Careers
    • HWI group team
    • Vacancies
    • Career and family
  • Blog
 

How to find us

Rülzheim site

Frankfurt site

Appenweier site

Contact

Contact form


+49 7272 7767-0

info@hwi-group.de

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