Third Party Analytical Testing & Documentation Review

Third Party Analytical Testing & Analytical Documentation Review

Independent Laboratory Selection Support & High Resolution Data Integrity Review

Launching, importing, or distributing products in Canada or the United States requires laboratory data that is accurate, validated, and fully aligned with regulatory expectations. Whether you are developing pharmaceuticals, nutraceuticals, cosmetics, food products, or raw materials, the reliability of your analytical testing directly impacts your regulatory compliance, market entry, and quality assurance outcomes.

Arirex provides a combined analytical oversight service that integrates independent laboratory suitability evaluation with comprehensive analytical documentation review, ensuring that all testing supporting your product decisions is scientifically defensible and regulator ready.

Critically, Arirex maintains strict independence—we do not endorse, partner with, or recommend any specific laboratories. Our role is to provide objective, compliance based evaluations so clients can make informed decisions without compromising our auditing impartiality.

A. Third Party Analytical Testing Coordination (Independent Guidance)

Helping You Assess Suitable Laboratories in Canada & the USA

Selecting the right analytical laboratory is essential for compliant market entry and product quality. Arirex supports clients by providing independent, unbiased evaluation criteria to help them identify laboratories capable of meeting regulatory and technical requirements.

⭐ Independence & No Conflict of Interest

Arirex does not approve, endorse, or maintain commercial partnerships with any analytical laboratory. Our role is purely advisory and evaluation based. The final selection always remains with the client. This approach ensures:

• Full impartiality
• No conflict of interest with Arirex’s auditing services
• Total regulatory integrity

Regulatory Frameworks Used in Laboratory Evaluation

Arirex evaluates laboratory suitability against standards commonly reviewed during inspections in Canada and the United States, including:

• ISO/IEC 17025:2017 (Testing & Calibration Laboratory Competence)
• Health Canada GMP requirements (Part C, Division 2)
• FDA 21 CFR Parts 210/211 (Drug GMPs)
• GLP requirements under 21 CFR Part 58
• USP, EP, and JP compendial requirements
• ICH Q2(R1) (Analytical Method Validation)
• ALCOA+ Data Integrity Principles

This ensures your selected laboratory has the technical maturity, accreditation scope, and process control necessary to support compliant testing.

Independent Laboratory Suitability Assessment

Arirex provides objective evaluation in the following areas:

• Accreditation under ISO/IEC 17025
• Technical capability for your product matrix
• Availability of validated or compendial methods
• Instrumentation readiness (HPLC, GC-MS, ICP-MS, LC-MS/MS, etc.)
• Review of regulatory inspection history (where publicly available)
• Evidence of robust data integrity systems
• Turnaround time feasibility
• Method suitability and alignment with ICH Q2(R1)

B. Analytical Documentation Review Services

Ensuring Your Data is Scientifically Valid & Regulator Ready

Analytical testing is only as strong as the documentation supporting it. Arirex performs detailed analytical data reviews to ensure accuracy, traceability, and compliance with Canadian and U.S. regulatory expectations.

This service is essential for:

• Product release decisions
• Importation requirements
• Supplier qualification
• Regulatory submissions
• OOS/OOT investigations
• Quality risk assessments

Full Analytical Package Review

Arirex reviews the complete analytical dataset, including:

All reviews are aligned with: ICH Q2(R1), USP / EP / JP, FDA & Health Canada data integrity expectations, and ALCOA+ principles.

COA Verification & Regulatory Alignment

Arirex verifies that COAs are accurate, complete, traceable, aligned with compendial or internal specifications, and suitable for importation and product release. This ensures your COA stands up to regulatory scrutiny.

Method & Specification Compliance Review

Our evaluations include validation parameters, appropriateness for the product matrix, system suitability, and identification of gaps or risks affecting confidence in results.

OOS / OOT Investigation Assessment

Arirex assesses root cause analysis credibility, Phase I and Phase II investigation quality, CAPA adequacy, and potential data integrity concerns.

Executive Analytical Interpretation Report

Clients receive a clear, concise interpretation summary covering:

• Data reliability
• Regulatory risk assessment
• Release vs. rejection recommendation
• Supplier performance considerations
• Suggested corrective actions

This helps quality leaders make confident decisions.

Why Companies Choose Arirex

• ✔ Fully independent—no endorsed labs, no partnerships
• ✔ Strong alignment with FDA, Health Canada & ICH expectations
• ✔ High resolution evaluation of complex analytical data
• ✔ Protects your regulatory compliance and minimizes risk
• ✔ Suitable for pharmaceuticals, cosmetics, food, nutraceuticals & raw materials

Arirex provides the clarity, independence, and technical depth needed to ensure your analytical testing supports compliant market entry and sustained quality assurance.