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

Regulatory services
Regulatory services

Regulatory services

We support you with the development, marketing authorisation and life cycle management of your medicinal products and combination products.

With our many years of expertise in medicinal products with chemical and biotechnological active ingredients and in combination products, we support you in the regulatory issues of product development and drug safety.

We efficiently guide you through the various development phases and support you in implementing regulatory requirements in a changing environment. We also offer further support from clinical, preclinical and regulatory experts from the HWI network.

Benefit from our knowledge gained from numerous marketing authorisation procedures for human and veterinary medicinal products with chemically defined active substances, phytopharmaceuticals and biological medicinal products, which we have accompanied or carried out independently on behalf of clients.