Christian Hilgenstock and Bernd Vens-Cappell are heading our consulting team dedicated to trial design and regulatory support for the pharma- and biotech-industry. Our consulting services ensure that regulatory requirements are considered and met from the beginning of clinical development.

The services offered are tailored to the needs of the client and may include the following:

• Review of existing data
• Further literature research and evaluation
• Development of trial design under consideration of international accepted guidelines and recommendations
• Discussion of design proposal
• Special assistance for NON-EU-Clients
• Support of IMPD preparation
  • Discussion with authorities and ethics committee
  • Drug import procedures