Policy matters
Supporting organisations in navigating legislation and regulatory requirements — through applied best practices in shaping intelligence, commenting processes, and association engagement.
Advice for policy, quality and regulatory excellence
Dr.-Ing. Stephan Rönninger supports organisations with senior-level advice in policy matters, holistic quality management systems, regulatory compliance, and resilient supply chain frameworks. The perspective is shaped by decades of international industry experience, association leadership, and active engagement in global pharmaceutical regulatory standardisation.
My offering
Turning regulatory complexity into practical approaches
Quality Management Systems
Advising on the design and implementation of integrated global QMS/PQS structures, grounded in risk-based principles across regulatory compliance, environmental aspects, and quality management procedures.
Regulatory compliance
Enabling Organizations and Marketing Authorization Holders in navigating GMP/GDP compliance, audits, and regulatory inspections — anchored in Quality by Design, CMC, and Quality Risk Management principles.
Resilient Supply Chain
Providing strategic guidance on resilient supply chain frameworks — spanning GDP compliance, distribution structures, supplier qualification, and proactive shortage prevention.
My experience
30+ years in industry, associations, and academia.
The profile combines site manufacturing experience, global quality leadership, policy work, association representation and academia.
Industry
From process optimisation and manufacturing to global quality management and GMP/GDP strategy and external engagement across leading pharmaceutical organisations.
Associations
Deep involvement and leadership in EFPIA, ICH, PDA, and IFPMA, including writing positions papers and guidelines, advisory and board-level contributions.
Academia
Adjunct Assistant Professor
George Washington University, Washington D.C., USA (2016 - 2019)
Academic Visiting Expert
Duke-National University of Singapore (NUS), Singapore (2018 - 2025)