Pharma • Biotech • Medical Device • Regulated Industries

Trusted Quality, Regulatory & Audit Readiness for Life Sciences

DQX Consulting Inc. helps organizations strengthen quality systems, improve inspection preparedness, manage compliance risks, and maintain practical, audit-ready operations.

Practical quality and compliance expertise for regulated organizations.

Focused support across quality systems, audits, and regulatory readiness.

Quality Management Systems (QMS)

Support for QMS design, gap assessment, procedure improvement, documentation practices, and sustainable quality operations.

Internal, Supplier & Medical Device Quality Audits (ISO 13485)

Independent audit support for internal quality audits, supplier qualification assessments, and medical device quality system audits aligned with ISO 13485 and applicable regulatory expectations.

Complaint Handling

Practical support for complaint intake, investigation, trending, documentation, and escalation pathways within regulated quality systems.

CAPA & Deviation Management

Structured support for deviations, nonconformances, CAPA plans, effectiveness checks, and quality event closure.

Root Cause Analysis

Clear, evidence-based root cause investigation support using practical tools and risk-based thinking.

Regulatory & Inspection Readiness

Readiness support for Health Canada, FDA, ISO, and GMP expectations, including mock inspection preparation and response support.

Risk Management

Risk-based quality support to identify, assess, control, and monitor compliance and operational risks.

Continuous Improvement

Quality improvement initiatives that strengthen processes, reduce recurrence, and improve inspection confidence.

Clear, practical, and inspection-ready.

Assess

Understand current systems, risks, documentation, and business priorities.

Improve

Develop practical actions that align with regulatory expectations and operational realities.

Sustain

Support long-term quality maturity through follow-up and continuous improvement.

Quality assurance, regulatory compliance, and audit readiness support.

DQX Consulting Inc. provides expert quality assurance, regulatory compliance, and audit readiness support for pharmaceutical, biotechnology, medical device, and other regulated industries. We help organizations strengthen quality management systems, improve inspection preparedness, manage compliance risks, and deliver practical support for internal audits, supplier audits, medical device audits, CAPA, complaint handling, root cause analysis, and continuous improvement.

Our focus is to provide clear, practical, and risk-based consulting that supports compliance while helping organizations operate with confidence.

Ready to discuss your quality, compliance, or audit readiness needs?

Book a consultation or send a message using the form below.

Messages can also be sent directly to arodkoli@dqxconsulting.ca