Core capabilities
- Gap assessments and risk ranking
- Inspection response strategy
- CAPA program redesign
- QMS process rebuild
- Interim quality leadership
Service capability
Turn quality drift into a controlled recovery program.
From warning letter response to system rebuild, BEPC drives remediation plans that stand up to reinspection.
Execution deliverables
- Remediation roadmap and governance cadence
- Regulatory communication package
- Sustained-control KPI model
Compliance framework
FDA QSRICH Q10EU GMPISO 13485
Typical engagement
Post-Observation Stabilization
Cross-functional war room, deviation triage, and regulator-facing narrative control.
Typical engagement
Quality System Overhaul
Six-month phased redesign of CAPA, complaints, and change control with role-based training.