Quality Assurance (QA)

Quality Management Systems (QMS): Design & Implementation

Purpose-built to match your development phase — from proof-of-concept and preclinical through clinical and commercial operations — with scalability built in.

• Phase-appropriate QMS architecture.

• Document development aligned to operational maturity.

• Training program design (foundational → advanced).

• Validation planning and support matched to stage of development.

Every system is designed to scale — from lean startup operations to full commercial readiness.

Audits & Inspection Readiness

Comprehensive support at every stage of growth — from seed to scale-up.

• Internal audits and pre-approval readiness assessments

• Mock regulatory inspections (PAI, BIMO, EMA)

• Remediation planning and regulatory response strategy

• Supplier and vendor audit management across the lifecycle

Right-sized inspection preparedness for small teams and complex organizations alike.

Training, Development & Organizational Readiness

Customized programs tailored to your team’s experience, size, and regulatory exposure.

• Phase-specific GMP/GDP/GCP training

• Inspection readiness coaching and scenario-based preparation

• Role-based competency and qualification modules

• Training effectiveness assessments and refresh strategies
  
  

From foundational compliance to advanced technical skill-building — designed to support readiness at every stage.

Process Performance & Continuous Improvement

Establishing sustainable quality oversight and operational insight as you scale.

• KPI framework development (leading and lagging [metrics] indicators).

• Quality review management and governance routines.

• Deviation, Investigations, and CAPA trend analysis.

• Data-driven decision support (dashboards and analytics).
  
  

Building the metrics and insights today that will anchor your future governance framework.