HWI Group - Regulatory services

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Company
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, Frankfurt and Appenweier.

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.
- Pharmacovigilance & QP services
  
  Pharmacovigilance
  
  QP services
  
  Pharmacovigilance and QP services
  
  Our interdisciplinary team offers all services relating to pharmacovigilance, quality management and batch release.
  
  Pharmacovigilance and QP 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.
  
  QP services
  
  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.
- Drug development
  
  Drug development
  
  Small batches
  
  Clinical trial batches
  
  Product life-cycle
  
  360°Cleanroom
  
  Drug development
  
  In formulation development, we offer galenic and analytical development for solid, semi-solid and liquid dosage forms.
  
  Drug development
  
  In formulation development, we offer galenic and analytical development for solid, semi-solid and liquid dosage forms.
  
  Small batches
  
  In the manufacturing area, we specialise in the production small market batches under GMP conditions.
  
  Clinical trial products
  
  In the manufacturing area, we specialise in the production of clinical trial products under GMP conditions.
  
  Product life-cycle
  
  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.
  
  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 services
  
  Regulatory services
  
  Product development
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
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.
Blog

How to find us

Contact

Newsletter

Hotline

Monday - Friday

+49 7272 7767-0

Careers

Training/work placements

Hotline