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
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