Your partner in pharmaceutical quality management
Based in Basel, Switzerland, SN Quality Consulting provides tailored solutions for pharmaceutical companies seeking to achieve and maintain regulatory compliance, optimize their quality systems for improved efficiency and effectiveness, and cultivate a culture of quality excellence.Leveraging 35 years of experience within the Swiss pharmaceutical industry, we partner with you to meet your specific needs and ensure the highest standards of quality.
Where we help
GMP Compliance Audits & Gap Analysis
Comprehensive audits of your facilities and processes to identify areas of non-compliance with Good Manufacturing Practices (GMP). We provide detailed reports and actionable recommendations to close gaps and ensure regulatory readiness.
QMS Development & Implementation
Design, implementation, and optimization of robust and efficient QMS tailored to your organization's specific needs and regulatory requirements (e.g., GMP, GDP, ISO 13485, MDR).
Regulatory Consulting & Support
Expert guidance on Swiss and international pharmaceutical regulations, including support for health authority inspections, notified body audits, and license to operate maintenance.
Training & Coaching
Customized training programs and one-on-one coaching for quality professionals at all levels, covering topics such as GMP, GDP, quality risk management, and data integrity.
About me
Dr Stefan Niesel
I am an experienced Quality Management leader with over 30 years of expertise in the pharmaceutical industry, specializing in driving change and growth within Quality Assurance, Quality Control, and GxP/compliance. I help companies build and optimize robust Quality Management Systems (QMS) to achieve regulatory compliance, improve operational efficiency, and foster a strong quality culture.My experience spans a wide range of products, from Rx and Biotech to OTC and Medical Devices, giving me a comprehensive understanding of the regulatory landscape.I have a proven track record of successfully leading teams of up to 100 people across global headquarters, divisional hubs, and manufacturing sites, developing and implementing innovative QMS solutions that ensure product quality, safety, and effectiveness throughout the product lifecycle.
