Services
Execution
Ad Interim FvP in case of personnel requirements / change
Support and relieve the FvP
Support for quality issues (change control, deviations, CAPA, complaints, etc.)
Support for GMP/GDP issues
Training
Training on GMP/GDP topics
Development of training concepts, training matrices
Information about innovations/adjustments regarding regulatory requirements
Consulting
Compliance support including GAP analyzes to determine the current GMP/GDP compliance status
Development, improvement or redesign of the quality management system (QMS)
Auditing / Inspections
Self-inspections (analysis of the current situation)
Mock audits for inspection preparation/inspection readiness
Advice and support for upcoming audits (preparation, monitoring and follow-up of inspections, including rectification of defects)
Subcontract audits (contract manufacturers, suppliers and service providers, including qualification)
