Services and expertise in Drug Development: from drug candidate to proof of concept

We are committed to translating innovative drug research into therapeutic applications – safely, reliably and efficiently. Based on our scientific expertise, we offer appropriate methods and approaches for this purpose. With a development strategy tailored to your product, we support you in process development and manufacturing of your active biopharmaceutical ingredient and sterile investigational medicinal product, in preclinical testing – both pharmacology and toxicology – and in early-phase clinical trials from first-in-human to the clinical proof of concept.

Our state-of-the-art equipment and innovative research approaches allow us to develop new methods and techniques – also in cooperation with you and beyond the scope of our own services. Already in the early phase of drug development, we provide assistance as independent consultants and negotiators in the dialog between applicant and regulatory authority. We work in compliance with regulatory and legal requirements for drug development – quality platforms according to GLP, GMP, and GCP standards are available for this.

 

Manufacturing of active biopharmaceutical ingredients and IMPs

Development of API manufacturing processes and GMP biomanufacturing of IMPs including fill and finish

 

Regulatory research and risk assessment

Tailored regulatory research in close cooperation with authorities

 

Preclinical testing

Customized toxicology studies and unique disease models

 

Clinical trials

Early-phase clinical trials, proof of concept for respiratory medications

Contact

Holger  Ziehr

Contact Press / Media

Dr. Holger  Ziehr

Coordinator of the Business Unit Drug Development

Fraunhofer-Institut für Toxikologie und Experimentelle Medizin
Inhoffenstr. 7
38124 Braunschweig

Phone +49 531 6181-6000

Henning  Weigt

Contact Press / Media

Dr. Henning  Weigt

Coordinator of the Business Unit Drug Development

Phone +49 511 5350-329