Core Expertise & Services
Comprehensive Quality & Compliance solutions tailored for pharmaceutical and bio/nanotech environments.
Operational QA & Batch Release
Hands-on execution on the shop floor to eliminate backlogs and maintain uninterrupted supply chain flow.
- Batch Record Review (Biologics / API / Annex 1)
- Deviation Management & CAPA
- Root Cause Analysis (RCA)
- QP Support & Documentation
GMP Compliance & Audit Management
Ensuring full regulatory readiness for EU (EMA) and US (FDA) compliance frameworks.
- Inspection Readiness Programs
- Self-Inspections & Supplier Audits
- Mock FDA/EMA Audits
- Remediation Strategies
Executive QA Advisory & Leadership
High-level strategic oversight and QMS optimization for growing biotech and established pharma entities.
- QA Interim Management & Oversight
- QMS Setup & Implementation
- Executive Level Compliance Reporting
- Risk Management (ICH Q9)
SENIOR CONSULTANT & FOUNDER
A. Bawary
Senior Quality Assurance Specialist with extensive experience in leading cross-functional quality operations and compliance projects across European, US, and Asian pharmaceutical hubs.Instructor at the European Compliance Academy (ECA) specializing in Root Cause Investigations. Enrolled in Harvard Executive Education.
Specialized in resolving complex deviations, accelerating product releases, and providing pragmatic executive advice.