Services

Do you have questions regarding regulatory strategy, or CMC and quality topics?

Or are you looking for advice supporting the preparation or scientific review of regulatory and source documents (GMP compliant) for product-related submissions and interactions with authorities (CTA, IND, MAA, NDA, BLA)?

I am happy to offer independent advice for your subject matters. In particular, early consideration of regulatory requirements and the application of quality and scientific topics is crucial to successfully overcome the challenges during development as well as pre- and post-approval. As a lecturer/reviewer for the quality module of the postgraduate Master’s degree programme “Drug Regulatory Affairs” at the University of Bonn, in cooperation with the DGRA e.V., I am well aware about the benefit based on these interactions.

I assure you a thorough consideration and confidential collaboration.

Thank you for your interest – I look forward to hearing from you !