Quality & Compliance

Uncompromising quality systems aligned with global regulatory frameworks, ensuring safety, compliance, and operational excellence.

Frameworks & Standards

Our operations adhere to globally recognized regulatory frameworks and quality standards to ensure compliance at every stage.

FDA Regulations
  • 21 CFR Part 11
  • 21 CFR Parts 50 / 54 / 56
  • 21 CFR Parts 58 / 210 / 211
  • 21 CFR Parts 312 / 314 / 820
ICH Guidelines
  • ICH E6 (R2 / R3)
  • ICH E8 (R1)
  • ICH E9
  • ICH Q7 – Q10
ISO & GxP
  • ISO 9001
  • ISO 13485
  • GCP / GMP / GCLP
Data Privacy
  • HIPAA Compliance
  • GDPR (as applicable)

Inspection Readiness

We maintain a constant state of inspection readiness through structured processes, proactive compliance strategies, and continuous monitoring of quality systems.

  • Audit-ready documentation and traceability
  • Regulatory storyboards and structured narratives
  • Mock inspections and g ap assessments
  • CAPA effectiveness verification
  • Data integrity by design principles