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: [email protected]
senior pharma consultant
Dr. Monika Bucher-Rager
PhD in Virology. 10 years of experience in biopharmaceutical industry in leading positions in the process development and production of parenterals as well as in the function of QA Compliance Manager.
- Process design, scale-up
- Process validation
- Aseptic processing
- Cell therapy
- Risk analysis
- Biosafety
- Quality management
Phone: +41 (0) 79 391 30 27
E-mail: [email protected]
SENIOR PHARMA CONSULTANT
dr. philippe paroz
PhD in Microbiology. 40 years of experience in biopharmaceutical industry in Top-Management positions, such:
- Member of the International Operation Committee in international biopharmaceutical company
- Executive Vice-President in international biopharmaceutical company
- Qualified Person
- Member of Swiss gene therapy committee
Specialist for the following consulting activities:
- Contracted Qualified Person
- Vaccine industry
- Aseptic processing
- Training
- Project Management
- Audit
Phone: + 41 (0) 79 334 73 59
E-mail: [email protected]
Senior Meddev Consultant & Business Development Manager
Dr. Andrei Issakov
MD, MPH, PhD Surgery.
40 years of experience in clinical practice and public health at national and international levels including 24 years in senior positions with the World Health Organization and 7 years as international consultant. Extensively worked with various stakeholders such as governments, international organizations, academic and research institutions, industry and civil society, and implemented numerous multidisciplinary international projects in some 135 countries.
- International health networking
- Stakeholder engagement and partnership building
- Health systems and services organization and management
- Healthcare quality and patient safety
- Health technology assessment, planning and management with a special focus on medical devices.
Phone: +41 (0) 79 757 86 31
E-mail: [email protected]
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: [email protected]
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: [email protected]
Life sciences Consultant
susanne zeltner
Bachelor in Biotechnology. 10 years of experience in biopharmaceutical industry in Top-Management positions, such:
- Filling and Packaging processes of sterile and non-sterile products
- Aseptic processing
- Quality assurance
- Risk management
- Equipment qualification
- Process and Cleaning validation
Phone: + 41 (0) 79 373 51 39
E-mail: [email protected]
Life Sciences Consultant
Dr. Astrid Glück
PhD in Cellular and Biomedical Sciences
- Clinical Affairs
- QA Affairs
- Equipment Qualification
- Sterile Manufacturing
Phone: +41 (0) 79 413 02 04
E-mail: [email protected]
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
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
- Pharmasutical drug product production
- Hygiene concept for clean room operations
- Risk management
- QMS Experience
Phone: +41 (0) 79 560 00 08
E-mail: [email protected]
