ARIREX: Global Excellence in GxP Auditing & Regulatory Compliance
Bridging the Gap Between Operational Reality and Global Regulatory Expectations.
At Arirex, we believe that in the modern pharmaceutical and healthcare landscape, a GMP audit is far more than a simple regulatory hurdle—it is the foundational bedrock of product safety, patient trust, and brand integrity. As global supply chains grow in complexity and health authorities intensify their scrutiny, the need for a sophisticated, independent oversight partner has never been more critical. Arirex acts as your strategic force multiplier, transforming compliance from a mandatory requirement into a decisive competitive advantage.
Our global network consists of industry veterans and senior lead auditors strategically positioned across the globe, bringing decades of collective experience in Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Food Safety. We don't just "check boxes." Our experts perform deep-dive technical verifications, speaking the local language of the audit site and the technical language of the laboratory. Whether it is a sterile manufacturing facility in Europe, a chemical plant in Asia, or a clinical research site in the Americas, Arirex delivers the independent authority and technical depth required to ensure every link in your supply chain is robust, ethical, and fully compliant with FDA, EMA, MHRA, and other global health authority expectations.
Our Comprehensive Audit Portfolio
1. Pharmaceutical, Biologics & Preclinical GxP
We provide uncompromising quality oversight at every stage of the product lifecycle, from initial research to global distribution.
- GMP (Good Manufacturing Practice): Comprehensive audits for APIs, Excipients, finished dosage forms, and advanced therapies (Cell & Gene).
- Standards: ICH Q7 (APIs), EudraLex Vol. 4 (EU), 21 CFR Parts 210/211 (US), PIC/S GMP Guide, Annex 1 (Steriles), and Annex 2 (Biologics).
- GDP (Good Distribution Practice): Cold chain integrity and global logistics handler verification.
- Standards: EU GDP (2013/C 343/01), WHO TRS 1025 (Annex 7), and USP <1079>.
- GVP (Pharmacovigilance): Stress-testing your drug safety monitoring and signal detection systems.
- Standards: EMA GVP Modules (I-XVI) and 21 CFR 314.80.
- Preclinical (GLP): Laboratory audits ensuring non-clinical safety studies meet international standards.
- Standards: OECD Principles of GLP and 21 CFR Part 58.
2. Medical Device & IVD Precision
Navigating the shifting regulatory frontier with specialized third-party auditing and verification services.
- ISO 13485:2016: Embedding risk-based thinking into the DNA of your Quality Management System.
- Standards: ISO 13485:2016, ISO 14971:2019 (Risk Management), and ISO 9001:2015.
- MDSAP (Medical Device Single Audit Program): One unified audit to satisfy the US, Canada, Brazil, Japan, and Australia.
- Standards: MDSAP Audit Model (covering FDA 21 CFR 820, Health Canada SOR/98-282, TGA, MHLW/PMDA, and ANVISA).
- MDR/IVDR & UKCA: Technical file reviews and QMS gap analyses for European and UK market access.
- Standards: Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), and UK MDR 2002.
- Emerging Market Access: Specialized support for regional health authority requirements.
- Standards: SAHPRA (South Africa), HSA (Singapore), and MDA (Malaysia) regulatory frameworks.
3. Cosmetics, Food & ISO Standards
Applying pharmaceutical-grade rigor to consumer goods to mitigate risk and ensure global consistency.
- ISO 22716 (Cosmetics GMP): Diagnostic tools for production and quality control in alignment with international regulations.
- Standards: ISO 22716:2007 and Regulation (EC) No 1223/2009.
- Food & Nutraceuticals: Audits based on global safety standards and supplement-specific guidelines.
- Standards: ISO 22000:2018 (FSMS), FSSC 22000, HACCP, and EHPM Guidelines for food supplements.
- Specialized Standards: Expertise in primary packaging and ingredient integrity.
- Standards: IPEC-PQG GMP (Excipients), EFfCI GMP (Cosmetic Ingredients), and ISO 15378:2017 (Primary Packaging for Medicinal Products).
4. Internal Audit & Mock Inspections
Turn your audit process into a roadmap for superior performance and total inspection confidence.
- Independent Internal Auditing: An objective "second set of eyes" to identify "blind spots" that internal teams might overlook.
- Standards: ISO 19011:2018 (Guidelines for auditing management systems).
- Mock Inspections: High-fidelity simulations of regulatory visits to ensure your team is prepared for any health authority scrutiny.
- Standards: Aligned with FDA QSIT, EMA Inspection Procedures, and MHRA methodology.
- CAPA & Remediation Support: Technical evaluation of Corrective and Preventive Action plans to ensure long-term compliance stability.
- Standards: ICH Q10 (Pharmaceutical Quality System) and FDA Guidance on Quality Systems.
Arirex recognizes that "one size fits all" doesn't work in a borderless industry. We offer flexible, high-impact models designed to fit your timeline and budget:
- Shared Audit Platforms: Collaborate with industry peers to co-sponsor a single inspection, reducing costs and mitigating "audit fatigue" for suppliers.
- Virtual & Remote Inspections: Technology-forward solutions for real-time oversight without geographical or travel barriers.
- Audit Report Purchase Program: Gain immediate visibility into a supplier by purchasing existing, high-quality GMP reports conducted by our expert team.
Why Choose Arirex?
The pharmaceutical and healthcare sectors are under unprecedented pressure from volatile logistics and intensifying inspections. Arirex provides the Peace of Mind that comes from total quality confidence.
- Global Reach, Local Expertise: Auditors positioned worldwide with a sophisticated understanding of localized regulatory climates.
- Unbiased Technical Insight: Every audit report is a reflection of our commitment to technical accuracy, impartiality, and independence.
- Continuous Compliance: We don't just audit for today; we look at upcoming regulatory shifts (2025/2026) to ensure your market access remains uninterrupted.