ARIREX helps regulated organizations pass inspections, close compliance gaps, and build inspection-ready quality systems — through expert auditing, consulting, testing oversight, and training, delivered by practitioners who've sat on both sides of the audit table.
Auditing
Consulting
Testing Oversight
Training & Competency
Regulatory Compliance
Inspection Readiness
Auditing
Consulting
Testing Oversight
Training & Competency
Regulatory Compliance
Inspection Readiness
ARIREX is a consulting, compliance, and auditing firm dedicated to elevating operational standards across pharmaceuticals, biologics, food and beverage, medical devices, natural health products, cosmetics, and other regulated industries. Built on a foundation of integrity, technical excellence, and evidence-based decision-making, we provide clarity in highly controlled environments.
Across manufacturing, quality, regulatory affairs, and distribution.
Learn MoreEnsuring systems meet or exceed expectations from FDA, EMA, Health Canada, and others.
Learn MoreARIREX supports the full compliance lifecycle for regulated manufacturers and distributors — from independent audits to hands-on consulting, third-party testing oversight, and workforce training.
Independent GMP, GDP, GVP, ISO 13485, and ISO 22716 audits, mock inspections, and vendor/supplier qualification — across pharma, biologics, medical device, and cosmetics. GMP, GDP, GVP, ISO 13485, ISO 22716 — audited against US FDA, Health Canada, EU/EMA, and MHRA expectations.
Regulatory strategy, CAPA system design, quality management framework build-out, and inspection-readiness support tailored to your organization's scale and maturity. Aligned with US FDA, Health Canada, EU, and ISO 9001:2015 frameworks.
Third-party analytical testing coordination, data integrity review, and laboratory oversight — bringing an independent, audit-trained eye to your test data. Data integrity reviewed against ALCOA+ principles and 21 CFR Part 11.
SOP and GMP/GDP training, documentation-discipline reinforcement, and personnel competency programs that hold up under regulatory scrutiny. Programs built around current US FDA, Health Canada, and EU GMP/GDP training expectations.
With deep technical expertise across manufacturing, quality, and regulatory affairs, ARIREX ensures that compliance is not only achievable but sustainable.
With a strong presence in Canada, ARIREX provides organizations with local expertise and support that spans across North America, Europe, and Asia, bridging international regulatory gaps.
contact usWe respect the unique needs, scale, and maturity of each organization. We do not apply a one-size-fits-all approach; instead, we design custom systems that work for your operations.
contact usOur audits, mock inspections, and consulting are powered by deep technical expertise across manufacturing, quality control, and testing environments, making compliance achievable and sustainable.
contact usOur approach is methodical, transparent, and grounded in real-world experience.
Our commitment is reflected in our core strengths.
Across manufacturing, quality, regulatory affairs, and distribution.
Supporting both routine operations and high-stakes regulatory interactions.
Ensuring recommendations are not only compliant but also efficient and scalable.
Ensuring clients remain compliant as regulations evolve.
A step-by-step methodology designed to ensure thorough evaluation, absolute accuracy, and sustainable regulatory compliance.
Defining audit boundaries, regulatory standards (GMP, GDP, ISO), and objectives.
Matching a certified lead auditor with specific technical and industry expertise.
Reviewing pre-audit records, agendas, and establishing clear communication.
Conducting on-site/remote checks, interviews, and detailed document reviews.
Delivering a detailed audit report with precise findings, gaps, and actions.
Supporting CAPA tracking, evidence resolution, and final compliance sign-off.
We've compiled answers to the most common questions about our audit process, engagement scope, and service capabilities
ARIREX conducts supplier and vendor qualification audits, internal and mock regulatory inspections, system-based GxP audits, for-cause audits. We audits across pharmaceutical, biotech, medical device, cosmetics, and food sectors against FDA, EMA, MHRA, Health Canada, ISO, ICH, and PIC/S standards.
Yes. ARIREX offers both on-site and remote audit formats. Remote audits use structured document review combined with live video walk-throughs of facilities. The appropriate format depends on audit objectives, scope, and client preference.
Duration depends on scope, facility size, and audit type. A focused supplier qualification audit may require 1-2 audit days. A comprehensive GxP system audit of a manufacturing site typically require 3-5 audit days plus pre- and post-audit preparation. We scope timelines accurately at the start of every engagement.
We serve pharmaceutical manufacturers, biologics and biosimilar developers, medical device and IVD companies, contract research organizations (CROs), CDMOs, cosmetics and nutraceutical producers, and food companies subject to FSMA or equivalent frameworks.
The fastest way is to book a free 30 minute consultation using the booking button this page. Alternatively, complete the inquiry form on our Contact page - our team will respond within one business day to discuss your needs and propose a scoped engagement.
ARIREX supports clients across North America, Europe, and Asia, with audit and consulting engagements delivered on-site or remotely depending on location and scope.
