Dr. Rainer Boenigk has founded Boenigk Consulting GmbH in order to offer a broad service and expertise platform of an international senior consultant team and partner network to clients of Pharmaceutical, Biotechnology and Medical Device Industry. Dr. Boenigk is a microbiologist with more than 20 years of international experience in pharmaceutical, medical device and in-vitro diagnostic industry. He held various functions in Quality Management and General Management, amongst others as Vice President Quality and Regulatory Affairs with global responsibility on executive management level. Significant operational experience with P&L responsibility as plant manager. Extensive expertise in the establishing and re-organizing Quality Management systems (GMP, QSR), Regulatory Affairs, Crisis- and Risk Management. Leading global FDA Compliance projects including inspection support and in negotiations with international health authorities (EU, US etc.) supported by profound experiences in change management, organizational restructuring, Lean Management and Interim Management.