Regulatory Affairs

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  One-stop shop
  
  Everything from one source: our expertise and experience in technology, analysis, marketing authorisation and drug safety for your projects.
  
  Technology platforms
  
  Our technology platforms for lean product development, troubleshooting or other complex matters relating to medicinal products.
  
  Partner network
  
  Benefit from our core expertise and our strong network of selected experts and partner companies.
- Quality management
- Contacts
- News
HWI group

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

HWI group

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

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.

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.
Services
- Laboratory
  
  Laboratory services
  
  Development and validation
  
  Impurities
  
  Quality control
  
  Laboratory
  
  We are your partner for pharmaceutical analysis and quality control. Our 29 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 29 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
  
  Reference standards
  
  Individual reference standard management
  
  Product range
  
  Referencestandards
  
  We have been involved in the preparation, purification and qualification of pharmaceutical reference standards for 29 years. This knowledge and experience makes us the ideal partner for your reference standards needs.
  
  Reference standards
  
  We have been involved in the preparation, purification and qualification of pharmaceutical reference standards for 29 years. This knowledge and experience makes us the ideal partner for your reference standards needs.
  
  Individual reference standard management
  
  We can handle your individual reference standard management for the just-in-time supply for your laboratory. Take a look at our services and your benefits.
  
  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
  
  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.
- Regulatory Affairs
  
  Medicinal products
  
  Active ingredients and excipients
  
  Medicinal products and medical devices combined
  
  Medical devices
  
  Product development
  
  Life-cycle management
  
  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.
  
  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.
  
  Active ingredients and excipients
  
  Without dossiers on active ingredients and excipients, there is no marketing authorisation/registration of medicinal products. We offer advice during the excipient or active-ingredient development process and when compiling and evaluating documentation for your dossier!
  
  Medicinal products and medical devices combined
  
  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.
  
  Product development
  
  The efficient development of new active ingredients and products needs a regulatory strategy right from the start. We provide regulatory, analytical and technical services so that you start off on the right path to obtaining your marketing authorisation.
  
  Life-cycle management
  
  We want to ensure there are no restrictions to marketing your products. New regulations, changing technologies, out-of-date documentation: we track the life cycle of your medicinal product and make all the adjustments for you. By the deadline.
Services

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

Campus

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Regulatory Affairs

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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.