End-to-end service concept

API

The quality of an active pharmaceutical ingredient is characterised by a number of chemical and physical characteristics that have a decisive influence on the quality of the finished product, its bioavailability, its stability and its other effects. With the aim of achieving optimal drug quality, it is essential to know the chemical and physical characteristics of the active ingredient in the early phase of drug development and to optimise them if necessary.

With the experience of many years and our large pool of analytical technologies and methods, we characterise your active substance and define these active substance properties required for optimal drug quality.

CMC development

We support you in the development and optimisation of solid, semi-solid and liquid dosage forms. Our spectrum ranges from tablets, hard capsules, film-coated tablets and granules to solutions and gels to technologically highly sophisticated formulations with poorly soluble active ingredients such as micro- and nanosuspensions. In addition to galenic development, our strengths are in analytical method development and regulatory support. In particular, we emphasise the wide range of chemical and physical analytical techniques that make the development process faster and more efficient. Process development and optimisation are among our core competencies. We always have in mind the scalability to later large-scale production.
In addition to our expertise in CMC development, you benefit from our extensive knowledge and experience in quality, preclinical and regulatory as well as our network for clinical development

Non-clinic

For the conduct of non-clinical in vivo and in vitro studies, we produce your formulation on a small scale under GMP conditions. With our partner institute, the Institute of Biochemistry and Molecular Biology at the University of Bonn, headed by Prof. Dr. Häberlein, we provide advice and support in the preclinical strategy and the conduct of preclinical studies on efficacy and tolerability as well as the elucidation of mechanisms of action (mode of action) in cell cultures or in animals.

Phase 1

We support you in preparation and implementation of your clinical trials and provide you with your clinical trial medication in accordance with applicable pharmaceutical standards and the highest quality standards.
From clinical conception to manufacturing, analytical release testing and QP batch release to distribution to the study centre, HWI is your reliable partner.

If you have a need to develop or optimise your product before the start of the clinical trial, please have a look at our CMC develoment to find out how HWI can support you.

Phase 2

We support you in preparation and implementation of your clinical trials and provide you with your clinical trial medication in accordance with applicable pharmaceutical standards and the highest quality standards.
From clinical conception to manufacturing, analytical release testing and QP batch release to distribution to the study centre, HWI is your reliable partner.

If you have a need to develop or optimise your product before the start of the clinical trial, please have a look at our CMC develoment to find out how HWI can support you.

Phase 3

We support you in preparation and implementation of your clinical trials and provide you with your clinical trial medication in accordance with applicable pharmaceutical standards and the highest quality standards.
From clinical conception to manufacturing, analytical release testing and QP batch release to distribution to the study centre, HWI is your reliable partner.

If you have a need to develop or optimise your product before the start of the clinical trial, please have a look at our CMC develoment to find out how HWI can support you.

Marketing authorisation

We support the marketing authorisation process with our broad expertise and many years of experience in drug development and manufacturing.

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.

The change management required for any changes to the product is also subject to strict regulatory requirements.

For your successful change management we offer: