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).

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.

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.

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

Regulatory Affairs
Regulatory services

Regulatory services

We support you with the development, marketing authorisation and life cycle management of your medicinal products, as well as with the classification, evaluation and certification of your medical devices, combination products and in vitro diagnostics.

With our many years of expertise in

we can advise you on strategic issues and demarcation issues, conduct gap analyses and regulatory evaluations and create the necessary reports and documentation. We can guide you through the various phases of development efficiently and successfully, supporting you in the implementation of regulatory requirements in a steadily changing environment.