ARIREX — Consulting Services
Regulatory Clarity. Sustainable Compliance.
ARIREX provides hands-on regulatory, quality, and compliance consulting for organizations navigating complex, multi-jurisdictional requirements. We design systems that hold up under regulatory scrutiny — built around your organization's actual scale and maturity, not a generic template.
Our Consulting Practice Areas
ARIREX's consulting practice covers nine core areas across the quality and regulatory lifecycle. Whether you need a single system redesigned or a full inspection-readiness program built from the ground up, our consultants bring direct industry leadership experience — not just theoretical frameworks — to every engagement.
1. Quality Management System (QMS) Design & Implementation
Design, build, and optimization of Quality Management Systems aligned to ISO 9001:2015, applying risk-based thinking and the Annex SL structure, tailored to your organization's size and regulatory scope.
Ideal for: organizations building a QMS from scratch or restructuring an existing one ahead of certification or customer audit.
2. CAPA System Design & Remediation
Design and remediation of Corrective and Preventive Action systems, including root cause analysis methodology, effectiveness checks, and closure documentation that satisfies US FDA, Health Canada, and EU expectations.
Ideal for: organizations with recurring CAPA findings or a backlog flagged during a prior audit or inspection.
3. Regulatory Strategy & Submissions Support
Guidance on regulatory pathway selection and submission strategy for US FDA, Health Canada, and EU/EMA frameworks, supporting product registration, variation, and lifecycle management activities.
Ideal for: companies planning a new product registration or navigating a regulatory pathway change.
4. Gap Assessment & Compliance Risk Management
Structured gap assessments benchmarking current practices against US FDA, Health Canada, EU GMP, and ISO 9001:2015 requirements, with a prioritized, risk-based remediation roadmap.
Ideal for: organizations preparing for a first-time inspection or entering a new regulatory market.
5. SOP Development & Documentation Systems
Development and restructuring of SOPs, master documents, and documentation hierarchies that meet GMP documentation-control expectations under US FDA, Health Canada, and EU GMP.
Ideal for: organizations with fragmented, outdated, or non-compliant documentation systems.
6. Data Integrity & Computerized System Validation (CSV)
Consulting on data integrity frameworks aligned to ALCOA+ principles, and computerized system validation aligned to 21 CFR Part 11 and EU GMP Annex 11.
Ideal for: organizations implementing new lab or manufacturing software, or remediating data integrity findings from a prior audit.
7. Change Control & Deviation Management Systems
Design and optimization of change control and deviation management systems that provide defensible, audit-ready documentation trails.
Ideal for: organizations experiencing delayed change implementation or inconsistent deviation handling.
8. Supplier & Vendor Quality Management
Development of supplier qualification programs, quality agreements, and ongoing vendor performance monitoring frameworks.
Ideal for: manufacturers managing multiple API, excipient, or contract manufacturing relationships.
9. Inspection Readiness & Regulatory Interaction Support
End-to-end preparation for US FDA, Health Canada, and EU/EMA inspections, including mock inspection debriefs, response strategy for observations, and front-room/back-room coordination support.
Ideal for: organizations with an announced or anticipated regulatory inspection.
Why ARIREX for Consulting
Practitioner-led
Our consultants have held quality and regulatory leadership roles inside the industries they now advise, not just consulting-firm backgrounds.
Right-sized solutions
Systems designed for your organization's actual scale and maturity, not an oversized framework built for a much larger company.
Built for inspection, not just paperwork
Every system we design is built to hold up under a real regulatory review.
Our Consulting Process
Assess
Reviewing current systems, documentation, and regulatory exposure.
Design
Building a scoped solution matched to your organization's size and risk profile.
Implement
Supporting rollout, training, and change management.
Validate
Confirming the system performs as intended under real operating conditions.
Sustain
Ongoing support as regulations and your organization evolve.
Ready to strengthen your compliance systems?
Book a free 30-minute consultation and we'll help you identify the right starting point for your organization.
Book a Consultation