Service
We provide specialized quality and compliance services to help organizations prepare, perform, and succeed in regulated industries.
Quality Managemeant Systems (QMS)
Robust QMS frameworks tailored to support regulatory compliance, operational excellence, and continuous improvement. We optimize your documentation, training, and quality processes to meet global GxP standards.
- SOP Development & Review
- QMS Digitalization Strategy
- Document Control Solution
- Change Control Process Design
- CAPA & RCA Design
- Gap Assessments
- Staff Training Programs
Audits
Prepare your teams and systems for regulatory inspections with proactive planning, simulation, and support. We ensure end-to-end readiness with strategic gap remediation and real-time inspection support.
- Investigator site audits
- Training on Inspection Conduct & Documentation
- Vendor Qualification Audits
- eTMF Reviews
- Mock FDA/MHRA Inspections
- Corrective action follow-up
Quality Metrics & Analytics
Drive smarter quality decisions with custom metrics, automated dashboards, and AI-powered performance tracking. Our metrics services improve visibility, efficiency, and compliance across your quality systems.
- KPI & Quality Metrics Framework Design
- Interactive Dashboards & Reporting Tools
- AI Integration for Trend Analysis
- Metrics Interpretation & Risk Flagging
- Metrics-Based Training Programs
- Quality Data Governance Planning
- Continuous Metrics Monitoring Services
GxP Advisory & Compliance
Expert regulatory guidance to ensure GCP, GMP, and GLP compliance across clinical and manufacturing operations. Our advisory services help you meet global standards and reduce compliance risk at every stage.
- GCP/GMP/GLP Compliance
- Compliance Documentation Review
- Regulatory Gap Assessments
- Study start-up & Due Diligence
- Risk-based Monitoring
- Quality by Design Strategies
Inspection Readiness
Prepare your teams and systems for regulatory inspections with proactive planning, simulation, and support. We ensure end-to-end readiness with strategic gap remediation and real-time inspection support.
- Inspection Readiness Planning & Execution
- Mock Regulatory Inspections (FDA/EMA/MHRA)
- Gap Analysis & Corrective Roadmaps
- Inspection Day Logistics & Coaching
- Post-Inspection Response & CAPA Tracking
- Training on Inspection Conduct & Documentation
- Inspection Readiness Health Checks
