Con- sulting.
Production-process definition, GMP compliance, regulatory-agency approval and quality-system implementation — strategic support in the service of performance.
Trois areas of expertise.
Our consulting team works upstream of the project — to secure structural decisions and prepare regulatory audits.
Production-process definition
Flow mapping, zone sizing, cleanliness-class definition, optimized layout drawings.
GMP compliance
Bringing operations into compliance with Good Manufacturing Practice — gap analysis, action plan, remediation follow-up.
Regulatory approval & QMS
Audit preparation, regulatory-agency approval dossiers, implementation of quality-management systems.
From audit to deployment.
Initial diagnosis
Site visit, document review, identification of gaps against the target standards.
Action plan
Action prioritization, cost/time estimation, remediation scenarios.
Support
Action-plan management, procedure drafting, training of operational teams.
Inspection readiness
Mock audit, approval dossier, support on the day of the regulatory inspection.