 |
Development concepts: In cases of line-extension or the development of dosage forms with
"added value" and novel combination products, creativity and experience-based
perspectives are advantageous in the identification of potential clinical benefits and
market opportunities.
|
|
Study findings: Occasionally results obtained in clinical trials are ambiguous. In such
cases it is important to interpret them appropriately considering the regulatory
requirements. Our experience with such situations may be helpful.
|
|
Biopharmaceutics: Comprehensive in-vitro testing of medicinal products should be standard
prior to the start of clinical trials. An appropriate interpretation of the findings with
respect to potential consequences for the in-vivo performance is often difficult and
requires intensive experience and specific expertise.
|
|
Registration strategy: Regulatory requirements essential for drug
registration should already be taken into account when development concepts and study
design are defined. Which is the reason why we prefer to involve regulatory affairs
specialists in project discussions as early as possible.
|
Solving such problems is our daily business. We look forward to constructive discussions with your
experts.
