Quality & Compliance

NOVARTIS HEALTH LIMITED Quality & Compliance
Regulatory Excellence

Reliable quality systems from sourcing to delivery

Our integrated quality framework ensures every product and service meets strict requirements for safety, efficacy, traceability, and market readiness across healthcare, pharmaceutical, and laboratory sectors.

100% batch-level traceability
24/7 quality incident response
3-Layer internal audit model

Global Standards We Follow

  • WHO-GMP aligned manufacturing and quality operations
  • FDA and EU regulatory guidance compliance support
  • ICH Q7, Q8, Q9 and Q10 quality system principles
  • GDP-compliant storage, handling, and transportation controls
  • Risk-based change control and CAPA governance

Quality Control Coverage

  • Raw material qualification and supplier risk profiling
  • In-process checks for consistency and process stability
  • Final lot release with documentation verification
  • Temperature and logistics integrity monitoring
  • Complaint handling, deviation analysis, and closure tracking

Our Compliance Process

01

Supplier & Material Qualification

Only approved suppliers and verified materials enter our workflow.

02

Controlled Production & Documentation

Critical steps are validated and recorded for full operational transparency.

03

Testing, Release & Distribution

Products are released only after QC review and regulatory checks are completed.

04

Post-Market Surveillance

We monitor outcomes, trends, and incidents to improve continuously.

Risk Management & Data Integrity

We apply a preventive, data-driven approach to quality using documented controls, periodic reviews, and escalation pathways to address potential non-conformance early.

  • Digital batch and document control logs
  • Audit trail verification for key records
  • Root cause analysis and preventive action plans

Documentation & Support

For partners, we provide regulatory and quality documentation packages to support import, registration, tender submissions, and due diligence activities.

  • Certificate of Analysis (CoA) and compliance records
  • Quality agreements and supplier documentation
  • Audit support and regulatory response coordination

Need quality documentation or compliance support?

Our team can help you with product-specific compliance requirements and partner onboarding.

Send Inquiry / Request Quote