Overview
We design, implement, and optimize Pharmaceutical Quality Systems aligned with ICH Q10, ensuring integration across development, manufacturing, and quality oversight functions.
Core Deliverables
QMS architecture aligned with lifecycle stage
SOP hierarchy (Level 1–4 documentation structure)
Deviation, CAPA, Change Control systems (risk-based)
Product Quality Review (PQR/APR) frameworks
Supplier qualification and quality agreements
Internal audit and management review systems
Regulatory Framework
ICH Q10 Pharmaceutical Quality System
ICH Q9 Quality Risk Management
FDA 21 CFR 210/211
EU GMP Part I / PIC/S PE009
Advanced Capabilities
Multi-site QMS harmonisation
eQMS migration and digital workflows
Inspection remediation and system restructuring
Outcome
An integrated, inspection-ready QMS that supports lifecycle management and continuous improvement.
