Manuel Zahn is managing director at 3R Pharma Consulting GmbH, Keltern, Germany. He specialises in regulatory affairs based on almost 30 years experience in the pharmaceutical industry. Dr Zahn contributed to the development of various international regulatory guidelines related to quality, in particular ICH, WHO and ASEAN. He has published over 30 papers, and delivered presentations at many international conferences and training courses. Since 1998, he has been an active member of the editorial board of The Regulatory Affairs Journal – Pharma. Dr Zahn gives advice on appropriate regulatory strategies for marketing authorisation applications, including review and assessment of regulatory documents.