Pharma & biotech
Quality, validation and maintenance consulting for pharmaceutical and biotech sites.
GMP production, without compromise
On a pharmaceutical or biotech site, every piece of equipment, every procedure and every piece of data must be justifiable to an inspector.
What we do
POMEX helps production, quality and maintenance teams meet this standard every day:
- qualification and validation (CQV, CSV) of equipment, utilities and computerised systems;
- GMP quality assurance: deviations, CAPA, change control, inspection readiness;
- structuring documentation and procedures;
- maintenance in a GMP environment: risk-based strategy, task justification, CMMS;
- capital project management, from design to start-up.
Our added value
Our consultants know the shop floor: they have worked in production, maintenance and quality on pharmaceutical and biotech sites.
How we work
Since 2013, POMEX has worked on sites in Wallonia, Brussels and northern France:
- assessment of your organisation and practices;
- project management, from defining needs to start-up;
- reinforcement of your quality, maintenance or project teams, for a specific assignment or period.
The expected result
Compliant facilities, inspection-ready files and teams in control of their processes.
Our expertise involved
Qualification & validation → · GMP quality assurance → · Asset management → · Project management & PMO →
