— Independent Expertise to Build Strong Quality Systems
Resolve Regulatory Issues & Support Global Market Entry
Organizations operating in regulated environments must demonstrate strong quality systems, consistent documentation, and full alignment with global regulatory standards. Arirex provides independent, high impact Quality, Compliance & Regulatory Consulting designed to help companies achieve, maintain, and elevate compliance across the entire product lifecycle.
Our services are delivered by senior industry professionals with practical expertise across pharmaceuticals, biologics, medical devices, cosmetics, nutraceuticals, food, and analytical laboratories. Arirex ensures your operations remain compliant, inspection ready, and aligned with evolving expectations from FDA, Health Canada, EMA, MHRA, WHO, ICH, and ISO.
🟦 OUR CONSULTING SERVICES
1. QMS & SOP Development for Startups and New Businesses
Build a Compliance Ready Foundation from Day One
New companies entering regulated markets need structured, compliant, and scalable Quality Management Systems. Arirex designs inspection ready, regulator aligned QMS frameworks tailored to your business model.
Our QMS & SOP Consulting Includes:
- Full Quality Management System (QMS) creation
- SOP development tailored to your operations
- Document control processes
- Deviation, CAPA & Change Control systems
- Training & competency program setup
- Batch release and documentation governance
- Supplier qualification and oversight frameworks
- Internal audit readiness (aligned with ISO 19011)
- Integration of risk management (ISO 14971 / ICH Q9)
Aligned With:
- GMP (FDA, Health Canada, EU, PIC/S)
- ISO 13485 (Medical Devices)
- ISO 9001 (Quality Management)
- ISO 22716 (Cosmetics GMP)
- HACCP / ISO 22000 (Food & Nutraceuticals)
- ISO/IEC 17025 (Laboratories)
- ICH Q7, Q8, Q9, Q10
Arirex ensures your new venture is compliant, scalable, and ready for audits or inspections.
2. Regulatory Observation Response Consulting
Expert Support for Responding to FDA, Health Canada, ISO & Audit Findings
If your organization receives inspection observations—such as FDA Form 483, Warning Letter, Health Canada inspection observation, or ISO nonconformity—Arirex provides the expertise required to develop strong, defensible responses.
We Support Response Development For:
- FDA 483 and Warning Letter observations
- Health Canada GMP observations
- ISO 9001/13485 nonconformities
- Supplier audit findings
- Data integrity observations
- CAPA system failures
- Documentation and procedural gaps
Our Response Framework Includes:
- Structured Root Cause Analysis (5 Whys, Fishbone, Barrier Analysis, FMEA)
- Corrective Action Plans aligned with regulatory expectations
- Preventive action strategy (ICH Q10 compliant)
- Remediation planning & implementation
- Evidence package creation
- Re inspection readiness support
We ensure responses demonstrate true root cause understanding, sustainable corrective action, and full regulatory alignment.
3. Quality, Risk & Compliance Strategy Consulting
Strengthen Your Systems with Expert Guidance
Arirex provides strategic consulting services to improve quality performance, minimize compliance risk, and ensure consistent execution.
Areas of Focus:
- Quality system optimization
- Risk management integration (ISO 14971 / ICH Q9)
- Data integrity program development (ALCOA+)
- Change control & deviation system review
- Supplier qualification strategy
- Documentation governance and lifecycle management
- Audit preparation (FDA, Health Canada, ISO)
- Quality culture development and leadership coaching
Arirex helps organizations build durable, future ready quality systems.
4. Market Entry & Regulatory Pathway Consulting (Canada & USA)
Clear Guidance for Launching and Distributing Products
Arirex helps organizations understand and meet regulatory requirements for launching or distributing regulated products in North America.
We Provide Support For:
- FDA (21 CFR 210/211, 820, 111, 58)
- Health Canada GMP & importation requirements
- NHP/Supplement regulatory expectations
- Medical device classification & documentation
- Cosmetic and food compliance pathways
- Documentation requirements for market entry
- Quality agreements & regulatory documentation alignment
We ensure your product is compliant from development through distribution.
5. Technical Documentation, Validation & Compliance Support
Inspection Ready Documentation for Regulated Operations
Arirex provides expert support for developing, reviewing, and optimizing technical and regulatory documentation.
Documentation & Validation Support Includes:
- SOP creation and optimization
- Quality manuals and technical files
- Batch record review & release frameworks
- Equipment qualification (IQ/OQ/PQ)
- Method validation (ICH Q2)
- Process validation (PV)
- Cleaning validation documentation
- Stability program design
- Importation & distribution documentation
We ensure your documentation is accurate, complete, and aligned with global regulatory standards.
🟩 WHY CLIENTS TRUST ARIREX
- ✔ Independent — no vendor partnerships; zero conflicts of interest
- ✔ Experienced — senior-level consultants with global regulatory backgrounds
- ✔ Technically Strong — deep expertise across GMP, GCP, GLP, GDP, ISO & ICH
- ✔ Regulator Aligned — guidance based on FDA, Health Canada, EMA, WHO expectations
- ✔ Startup Friendly — practical support for new or growing organizations
- ✔ Enterprise Ready — experienced with complex global quality systems
- ✔ Future Focused — anticipating regulatory shifts before they impact operations
Arirex brings clarity, structure, and confidence to your quality and regulatory programs.