Quality Assurance is embedded into every phase of the clinical development lifecycle; from early design through post-market operations.

Our QA framework ensures that every process, partner, and dataset meets the highest standards of GCP, ICH, and regulatory integrity.

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We combine human expertise with agentic intelligence to proactively identify risks, enforce compliance, and maintain continuous audit readiness across all programs.

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What’s Included

 

Quality Management System (QMS) Design & Implementation
Development and maintenance of scalable QMS frameworks tailored to study phase, sponsor type, and global compliance requirements.

 

Audit & Compliance Management
Comprehensive internal, external, and vendor audits (GCP, GMP, GDP, GLP).
Integrated audit scheduling, reporting, and CAPA oversight through cintl.ai.

 

CAPA Lifecycle Management
Automated issue tracking and resolution supported by real-time CAPA dashboards and workflow prioritization.

 

Inspection Readiness & Continuous Surveillance
Preparation for FDA, EMA, and MHRA inspections through predictive risk monitoring and digital evidence trails.

 

Continuous Quality Oversight
Integration of QA checkpoints within operational milestones to ensure real-time compliance throughout trial execution.

 

How CiNTL Pharma Adds Value

Agentic QA Workflows
Our AI-driven quality engine identifies emerging trends, recurring deviations, and potential systemic risks — before they impact data or compliance.

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• Dynamic Audit Intelligence:
  Live dashboards within cintl.ai connect audit findings, CAPAs, and training compliance across all study sites and vendors.

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Expert Oversight:
A global network of QA professionals with deep experience in FDA, EMA, PMDA, and WHO regulatory environments ensures global readiness.

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Outcome      End-to-end visibility across quality operations.

                        Reduced inspection findings and faster CAPA closure cycles.

                        Regulatory trust built through operational discipline and validated documentation.​​