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.

01. September 2018

HWI Campus – Your Solution for Your (Re-)Entry to Business in the EU

Following the Brexit, the United Kingdom (U.K.) will become a “Third country”. From October 31th, 2019 marketing authorisation holders based in the U.K. will need to have a registered office and/or a manufactu¬ring site with a corresponding manufacturing authori¬sation in the EU/EEA. For EU batch release and pharmacovigilance activities the QP and QPPV will also have to be resident here.

18. July 2018

#Brexit

"Brexit" will turn U.K. into a "Third Country" from 31st October 2019"

Following the Brexit, the United Kingdom (U.K.) will become a “Third country”. From 31st October 2019 marketing authorisation holders based in the U.K. will need to have a registered office and/or a manufacturing site with a corresponding manufacturing authorisation in the EU/EEA.

15. March 2018

#GPS

Pharmind Article: Lean Production Systems (LPS)

LPS and the pharmaceutical industry – how do they fit together?

Read the news-article.

12. September 2017

Start of HWI’s Incentive Programme

On 1^st September 2017 Nina Kern started her vocational training as chemical-technological assistant at the Natural Science Technical School Dr. Künkele in Landau.

12. September 2017

Career Day at the Integrated Comprehensive School (IGS) Rülzheim

Choosing a career is one of the most important decisions in young people's lives. It is the basis for the entire future life. This makes it all the more important for young people to be well informed about the possibilities and diversity of the various professions and sectors.