ARIREX provides organizations with the clarity, structure, and regulatory alignment needed to operate confidently in highly controlled environments.
Auditing Services
Regulatory Compliance
Quality Management
Mock Inspections
Training & Competency
Risk Management
Auditing Services
Regulatory Compliance
Quality Management
Mock Inspections
Training & Competency
Risk Management
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 MoreSupporting clients across North America, Europe, and international markets.
Learn MoreARIREX offers a comprehensive suite of consulting, compliance, and operational services designed to support organizations across the full lifecycle of regulated manufacturing and distribution.
Pharmaceutical and biologics manufacturing compliance, facility validation, and quality systems.
Good Distribution Practices, cold chain logistics validation, and supply chain integrity.
Good Pharmacovigilance Practices, drug safety systems, and adverse event reporting compliance.
Good Laboratory Practices compliance for preclinical studies, toxicology, and lab audits.
Unified GxP frameworks covering laboratory, manufacturing, and distribution activities.
ISO 13485 quality systems, QSR compliance, and CE marking/FDA readiness for medical devices.
Expert strategy, regulatory submissions, CAPA systems, and custom compliance frameworks.
ISO 22716 compliance, cosmetic GMP validation, and food safety quality assurance guidance.
Simulated regulatory audits (FDA, Health Canada) and comprehensive internal system reviews.
Third-party testing coordination, analytical data integrity reviews, and laboratory oversight.
SOP training, GMP/GDP compliance seminars, and documentation discipline reinforcement programs.
Global supply chain audits, vendor qualification, and regulatory compliance gap analysis.
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 and Europe, 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 lab services, research process, and 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.
