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.

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.

23. April 2020

HWI-Blog

Are you ready for new insights? Please visit our new HWI blog.

HWI expands with new location

HWI group takes over the Frankfurt development site of Losan Pharma GmbH and hereby extends its range of services.

17. December 2019

Merry Christmas & Happy New Year

We would like to thank our business partners very much for the good and trusting cooperation.

Successful cooperation is based on trust and understanding.

27. November 2019

#artificial intelligence

HWI wins AI Innovation Competition

As a partner of the KIKS ecosystem, HWI is a winner of the AI Innovation Competition by the Federal Ministry for Economic Affairs and Energy. KIKS intends to connect and evaluate medical data electronically in the future.

14. October 2019

#name change

Name change announcement

We would like to inform you that on 10^th October 2019 i.DRAS GmbH has changed its company name to HWI regulatory services GmbH. The new company name expresses the affiliation to the HWI group and the range of services offered by the company, which specialises in regulatory services.