GMP Consulting

Concept, interpretation, implementation

30 years of experience

Benefit from my broad expertise in GMP, Quality Assurance and Quality Management in the Pharmaceutical Industry - identify and fix your cGMP deficiencies before Inspectors do, develop sustainable and compliant concepts and comply with new requirements (FDA, EU, Swiss, ICH).

GMP Training

Routine GMP, Inspection, Specific Topics

On site or remote

Train the trainer, classroom or individual training, specific topics, routine GMP training, inspection readiness / behaviours in inspections training, cGMP practices, etc.

Audits and Inspection Management

Supplier and CMO Audit, Mock Inspection, Preparation

Lead Auditor

Get support with your Inspections and Audits: Gap Analysis, Mock Audits, Training, Strategy, Remediation Plan, Authority Response, CMO and Supplier Audits and Supplier Qualification.

GMP Routine Support

Hire a Professional to bridge your staff shortages

Quality Assurance

Get support with all your Quality Assurance tasks, e.g. Quality Oversight, Quality Projects, Batch Record Review and Technical Release, Change Management, Deviation and OOS Management, CAPA, Technical Quality Agreement, SOP, Contamination Control Strategy).

Quality Management System

Quality Strategy, Quality Manual, Quality Processes and Procedures

Robust and risk based

I help you to develop and implement your QMS or close the gaps in your existing QMS. Get your QMS Processes right (OOS and Discrepancy Management, Complaints, CAPA, Change Control, Process and Quality Monitoring, Training, Management Review, Validation, etc.)

Qualification and Validation

Strategy, Project Management, Support

Strategy and Project Management

Validation Strategy, Validation Masterplan, Project Management, Requirements Engineering (URS), GMP Risk Assessment, Qualification of Equipment, Consulting with regards to Qualification / Validation, Process Validation, Cleaning Validation

Your Benefit

30 years of experience in GMP and Quality Management

Silvana Frey





GMP Swiss Services

My range of services for the pharmaceutical, chemical, biotech industries includes GMP compliance consulting, audit & inspection management, quality assurance, quality management, quality systems, GMP training, GMP routine support and qualification & validation.

You decide whether you would like a consultancy, have a project implemented or book my expertise on a temporary basis for routine support in the areas of GMP, quality assurance or quality management.

After 30 years in the pharmaceutical industry in various local and global roles, I bring a very broad experience to efficiently support you in safely achieving your compliance goals.
I am very experienced with FDA, EMA, Swissmedic regulations and ICH and pharmacopeia requirements.

If you are interested, please contact me via e-mail, contact form or by phone.

Silvana Frey Owner, GMP Consultant
“With 30 years of experience in the Pharmaceutical Industry and GMP Consulting in various positions in Quality Assurance and Quality Management, Engineering and Project Management you will benefit from my extensive experience. I am very engaged, flexible and customer oriented and passionate about Quality and Solutions Excellence.”

Silvana Frey Owner, GMP Consultant

I will help you to achieve your GMP compliance goals

Experience – Trust – Effectiveness

Your GMP Expert

in Switzerland and Europe



GMP Expert

Quality originates from a mindset.


Please fill in the contact form for additional information or if you have a project which needs expertise and/or resources. I will be happy to provide my support.

    [designed by MacTech Buncak AG |]