team
Our professionals are committed
to pursuing excellence
in the services provided.
GENERAL MANAGER / SENIOR CONSULTANT
Stéphane Gumy
Degree in chemistry (HES).
With over 18 years experience for pharma, biopharmaceutical & medical device industry in small and medium-sized entreprises (SMEs) as well as in international companies leading QA, QC, manufacturing and process development groups. Since 2007 independent consultant. Since 2013 Qualified Person.
- Project management
- Aspects related to the compliance
- Risk analysis
- Third party audit
- Inter- or intra-company trainings
- Equipment qualification and CSV
- Media fill and process validation
Phone: +41 (0) 79 512 43 16
E-mail: stephane.gumy@pmsystem.ch
EXPERT CONSULTANT
Dr. Patrick Buschor
PhD in Immunology.
Expert in biopharmaceutical quality and regulatory affairs with over ten years of industry experience. Specialized in supporting innovative companies at the interface of GMP manufacturing and clinical development (GCP), with active engagement as a contracted Responsible Person (RP) for GMP (ATMPs) and GDP.
- Qualified Person / Responsible Person (GMP & GDP)
- Sterile manufacturing & ATMPs
- Lean quality management
- clinical trial sponsor oversight (GCP)
- Deviation and risk management
- inspection and audit readiness
Phone: +41 (0) 79 712 55 90
E-mail: patrick.buschor@pmsystem.ch
SENIOR MEDTECH CONSULTANT
GERD EICHHORN
Master’s Electrical Engineering with over 30 years of extensive experience in Medical Devices (MD) and In Vitro Diagnostics (IVD).
Expertise across all phases of the medical device product life cycle, from conception to product phase-out and replacement, including production.
- Recognized authority on all medical device standards and regulatory requirements in the EU (MDR/IVDR, LVD, Machinery), as well as international standards such as IEC 60601-x, IEC 62304, IEC 62366, ISO 14971, and FDA regulations for the USA market.
- Strong experience in electronic, mechatronic and embedded software as medical devices
- Former BSI auditor
- ISO 13485 & ISO 9001 Lead Auditor
Phone: +41 (0) 79 680 1349
E-mail: gerd.eichhorn@pmsystem.ch
senior pharma consultant
dr. lorenz rindisbacher
PhD in Microbiology.
Over 25 years of broad experience in pharmaceutical quality management for biologics (vaccines, biotechnology, blood products, life biotherapeutic products). Senior leadership roles in major international pharma companies. University lecturer in pharmaceutical quality management.
- Qualified Person / Responsible Person
- Strategic and operational quality management
- GxP compliance, compliance gap remediation, and health authority interactions
- Effective and efficient quality management systems and organizational design
- Quality by Design, Process Control Strategy
- Risk- and crisis management
- Supplier management and auditing
Phone: +41 (0) 79 947 84 81
E-Mail: lorenz.rindisbacher@pmsystem.ch
MEDTECH SENIOR CONSULTANT
PRAGASH VIJAY
Master in Biomedical Sciences.
Senior Regulatory & Quality Consultant specialized in EU MDR, IVDR and Swiss MedDO frameworks, with extended expertise in Computer System Validation (CSV) and data protection compliance within regulated healthcare environments.
Experienced in leading QMS implementation, regulatory remediation, digital validation projects and notified body interactions for medical devices and IVDs.
- Regulatory Strategy (EU MDR / IVDR / Swiss MedDO)
- PRRC – Regulatory accountability
- ISO 13485 – Quality Management Systems
- ISO 14971 – Risk Management
- Computer System Validation (CSV)
- Technical Documentation & CE Marking
- Audit & Inspection Readiness
- Certified Data Protection Officer (DPO)
Phone: +41 (0) 78 892 62 49
E-mail: pragash.vijay@pmsystem.ch
EXPERT CONSULTANT
MURIEL SOTTAS
Master in Life Sciences and Technologies.
Ten years of experience in biotechnology, quality assurance and GMP/GDP environments.
Scientific rigor, project-driven mindset, and efficient collaboration within multidisciplinary teams.
Strong expertise in quality system implementation and regulatory compliance.
Responsible Person for GDP activities since 2022.
- Quality system implementation and continuous improvement
- Risk management
- Cleanroom and equipment qualification
- Responsible Person
- Regulatory inspection support
- Audit
Phone : +41 (0)79 447 70 53
E-mail : muriel.sottas@pmsystem.ch
BUSINESS DEVELOPMENT MANAGER
felix pomares
Over 25 years’ experience as international sales manager and business development manager in chemical and life science industry.
Phone: +41 (0) 79 836 70 35
E-mail: felix.pomares@pmsystem.ch
Account & HR Manager
Manuela Gumy - Blatter
Phone: +41 (0)76 360 88 44
E-mail: buchhaltung@pmsystem.ch