Services "Quality means doing it right when no one is looking." - Henry Ford

Services

Thanks to GXP CONSULTING Switzerland's extensive knowledge about GXPs (GLP, GCP, GCLP, GDP & GMP) we can support our customers all along the product lifecycle offering tailored solutions in areas such as:

Process Development, Scale-up and Transfer

Technology Transfer
Test Coordination...

Quality Control

Laboratory management
Analytical methods development, validation and transfer
Metrology
Stability studies
Laboratory revamping...

Quality Assurance

Audit
Operational quality
Quality System management
Quality training, coaching, mentoring
Quality System improvement...

Qualification / Validation & Engineering

Process
Clean and black utilities
Facilities and equipment
Computerized and automated system
Cleaning validation...

Maintenance and manufacturing support

Optimise your maintenance and manufacturing
Team management...

Regulatory affairs

Lifecycle management
Pre-approval
Approval
Post-approval
Regulatory watch...

Clinical trials and safety

Clinical trials coordination
CRO selection and management
Operational quality...

Operational Excellence

Lean manufacturing
Lean organisation
Optimise your supply chain...

Project Management

Better organise and accomplish your project management activities

Trainings

From theory to practice, be up to date with the latest trends. We provide on demand trainings within our areas of expertise, with a real added value which is our hands-on experiences

DIGITAL TRANSFORMATION

Validation Lifecycle Management System (VLMS)
Application Lifecycle Management (ALM)
Product Lifecycle Management (PLM)
Advanced Planning and Scheduling (APS)
Change Management...

Areas

Our consultants have experiences in areas such as Biotechnologies, Pharmaceuticals, Medical Devices (ISO 13485, EN 62304, DHF, CE marking, 510K or PMA, Risk management EN ISO 14971, Usability, MDR, IVDR, MDSAP...), Combination products, Food, Cosmetics, e-Health, Biosimilars, Paperless Validation, Digital Transformation.

Delivery models

Time & Material

Technical assistance, consulting or expertise under Time and Material basis to support our customers.

Skills centre

You have access to a pool of competencies combined with KPI/SLAs related to management.

Flat fee

Commitment on deliverables, planning and budget to realise your project.