Diagnostics
Our Quality Assurance Consulting team helps organizations build and operate phase‑appropriate, inspection‑ready systems across cGMP, GLP, GDP and GCP environments.
We act as Contract Head of Quality, conduct internal and vendor cGMP audits, prepare teams for regulatory inspections, and design lean Quality Management Systems (QMS) including SOPs, training, deviations, CAPA and change control.
Comprehensive QA Services
End‑to‑end QA setup and oversight across development and commercial operations — aligned with WHO, ICH, PIC/s,and regional authority expectations (FDA, EMA, SFDA, MENA, MHRA, GHC and DRAP).
- Contract Head of Quality — operational QA leadership and oversight.
- cGMP auditing: internal, vendor, and for‑cause audits with corrective actions.
- Inspection readiness: pre‑approval, supplier qualification, mock audits.
- Quality Management Systems (QMS): SOPs, training, deviations, CAPA, change control.
- Risk management and data integrity (ALCOA+) implementation.
- Documentation control and batch record review programs.
- Ongoing compliance monitoring and KPI dashboards.
Contract Head of Quality
Interim or managed QA leadership to build processes, mentor teams, and maintain compliance during growth phases.
cGMP Auditing
Comprehensive EU/US cGMP audits for API, drug product, packaging, labs and suppliers — with actionable reports.
Inspection Readiness & QMS
Prepare for pre‑approval inspections with gap assessments, training, and document rooms; implement lean, phase‑appropriate QMS.
Our Approach
Build quality into processes from day one — risk‑based controls, clear ownership, and continuous improvement embedded in operations.
- Map processes to ICH Q9/Q10 with data integrity and role‑based training.
- Measure performance with CAPA effectiveness and audit KPIs.
Vendor Qualification
Qualify and monitor suppliers with technical agreements, scorecards, and periodic reviews.
Inspection Readiness
Mock audits, document review and team training to prepare for regulatory audits.
QA Partnerships & Compliance Network
We work with accredited training providers and specialist auditors to scale programs, harmonize procedures, and keep teams inspection‑ready.
QMS Implementation
Create SOPs, forms, training plans, and governance to sustain compliance.
Audit & CAPA Management
End‑to‑end audit lifecycle with corrective and preventive action effectiveness checks.
Inspection Readiness
Mock inspections, document room setup, and team coaching aligned to FDA/EMA/SFDA/MENA/MHRA/GHC/DRAP expectations.
Frequently asked questions about Quality Assurance
A service to build and oversee compliant systems: QMS setup, audits, CAPA, training, documentation control, and inspection readiness.
We map processes, write SOPs/forms, train teams, and deploy change control, deviation, and CAPA workflows with KPIs.
Internal, vendor, and for‑cause GMP audits covering API, drug product, packaging, labs, and suppliers.
Root‑cause analysis, risk assessment, action planning, effectiveness checks, and management review tracking.
ICH, EU/US GMP, GDP, GLP, GCP and regional frameworks (FDA, SFDA, GHC, MENA, MHRA and DRAP) for pharma, biotech, and healthcare.