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

News

News

Stay up-to-date. In our news section we regularly inform you about the latest news from HWI group.

09. October 2020

360° Cleanroom Tour

Enter our 360° Cleanroom here: 360° Cleanroom. Be right in the middle and take a look behind the scenes!

In our media centre you will find matching films about tableting under containment as well as the production and lyophilization of a nanosuspension.

HWI-Blog - the path of digital transformation

Digitisation is more than the introduction of new tools. Data protection, regulatory requirements, AI algorithms, above all "trust and values" play a major role.

Read more in our latest HWI-blog by Thomas Bögel why a good digitization strategy and AI are the pillars for standardization and quality improvement.

08. July 2020

Inside the clean room!

Today we are shooting with prestigefilm at our site in Frankfurt. Soon you will be able to take a look at the heart of our drug development.

HWI-Blog - Biological evaluation of medical devices

Would you like to know more about how ISO 10993-1:2018 provides a new intelligent approach to biological safety assessment?

Interested? Read more in our latest HWI-blog by Dr. Manuela Schwegler.

20. May 2020

HWI-Blog - Biopharmaceuticals

Are you prepared to develop biopharmaceuticals?

Biopharmaceuticals are unique and challenging and require a broad range of expertise to accelerate development and time to market and to mitigate associated risks.

Interested? Read more in our latest HWI-blog.