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

Consultant life sciences & Deputy General Manager
Dr. Patrick Buschor
PhD in Immunology. Five years of experience in biopharmaceutical industry in a leading role as Quality Assurance Manager for GMP certified manufacturing of parenteral drugs. Experienced in translational research and regulatory submissions.
- Project and QA management
- Sterile manufacturing
- Regulatory/Medical affairs
- Quality by design
- Lean solutions for QMS
- Process design, optimization and validation
- Risk analysis
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

LIFE SCIENCES CONSULTANT
DANIEL FALLEGGER
Master in Biochemistry. Experience in pharmaceutical industry (production and process development) for parenteral drugs products. Experienced in clean room operations as well as process engineering.
- Sterile manufacturing
- Equipment Qualification and Validation (DQ/IQ/OQ/PQ)
- Process Validation, e.g. Cleaning Validation
- Pharmaceutical drug product production
- Hygiene concept for clean room operations
- Risk management
- QMS Experience
Phone: +41 (0) 79 560 00 08
E-mail: daniel.fallegger@pmsystem.ch

MEDTECH CONSULTANT
PRAGASH VIJAY
Master in Biomedical Sciences
- Regulatory Affairs
- Quality Assurance
- Quality Management System
- Medical Devices: MDD & MDR
- In-Vitro Diagnostic Devices: IVDD & IVDR
Phone: +41 (0) 78 892 62 49
E-mail: pragash.vijay@pmsystem.ch

LIFE SCIENCES CONSULTANT
MURIEL SOTTAS
Master in Life Sciences and Technologies
- QA affairs
- Equipment qualification
- Biomanufacturing
- Diagnostic activities
Phone : +41 (0)79 447 70 53
E-mail : muriel.sottas@pmsystem.ch

LIFE SCIENCES CONSULTANT
MATHIEU GAILLARD
Bachelor in Biotechnlogy
- QA Affairs
- Equipment Qualification
- Computer System Validation
- Biomanufacturing
Phone: +41 (0) 79 638 14 57
E-mail: mathieu.gaillard@pmsystem.ch

Account & HR Manager
Manuela Gumy - Blatter
Phone: +41 (0)76 360 88 44
E-mail: buchhaltung@pmsystem.ch