Services

04 Dec 25

GxP System Setup

GxP System Setup Build a Strong, Inspection-Ready Compliance Framework Across GMP, GDP/GSDP, and GLP AGON designs and implements end-to-end GxP systems that strengthen compliance, streamline operations, and ensure pharmaceutical facilities are fully audit and inspection ready. Our solutions cover the complete lifecycle of manufacturing, distribution, and laboratory activities — enabling…

15 Oct 25

Gap Analysis

Gap Analysis Assess. Improve. Comply with Confidence. Agon ME conducts comprehensive Gap Analysis assessments to identify areas of non-compliance and develop a clear, actionable plan to achieve full regulatory alignment. Our detailed evaluations cover every aspect of facility, process, and documentation, ensuring adherence to authority requirements including USFDA, EU, JFDA,…

04 Dec 25

Pre-Assessment & Mock Audit

Pre-Assessment & Mock Audit Identify Compliance Gaps Early and Strengthen Inspection Readiness Before Regulators Arrive AGON supports pharmaceutical facilities in preparing for regulatory inspections through structured pre-assessments and mock audits. Our experts evaluate existing systems, processes, and documentation against GMP and international regulatory expectations to determine true readiness. By simulating…

04 Aug 25

Cleaning Validation

Cleaning Validation Clean Beyond Visible. Compliant Beyond Doubt. Agon’s Cleaning Validation services help you establish scientifically sound, regulator-approved cleaning processes that guarantee product safety, eliminate cross-contamination, and support multi-product facility approvals. From protocol development to analytical testing, we cover the full lifecycle of cleaning validation, ensuring every surface meets the…

04 Aug 25

Data Integrity

Data Integrity Build Trust into Every Record In an industry where every batch, test, and result matters, data integrity is non-negotiable. Agon’s Data Integrity services help pharmaceutical manufacturers build resilient systems that ensure every record is attributable, legible, contemporaneous, original, and accurate—aligned with ALCOA+ principles. Whether you operate on paper,…

04 Aug 25

Risk Assessment

Risk Assessment From Assumptions to Actionable Insights In the pharmaceutical industry, risk isn’t just a possibility—it’s a parameter that must be measured, managed, and mitigated. Agon’s Risk Assessment services enable organizations to proactively identify vulnerabilities in systems, processes, and products. Using globally recognized QRM (Quality Risk Management) methodologies, we help…

04 Dec 25

CAPA Issuing & Reviewing

CAPA Issuing & Reviewing Correct Issues. Prevent Recurrence. Strengthen Compliance. AGON supports pharmaceutical facilities in managing corrective and preventive actions (CAPA) to sustain compliance and strengthen operational efficiency. We help quality teams accurately identify deviations and non-conformities, implement corrective actions that eliminate root causes, and establish preventive controls that ensure…

04 Aug 25

Quality Metrics

Quality Metrics Measure What Matters. Improve What Counts. Quality can’t be managed unless it’s measured. Agon’s Quality Metrics service helps pharmaceutical companies define, track, and interpret critical quality indicators (CQIs) that align with regulatory expectations and internal excellence goals. From OOS trends to CAPA effectiveness, we empower your team to…

04 Aug 25

Process Validation

Process Validation Validate Once. Manufacture with Confidence. A validated process is your strongest proof of control and consistency. Agon’s Process Validation services help pharma manufacturers design, execute, and document validations that stand up to scrutiny—from regulators and internal stakeholders alike. Whether you’re launching a new product or revalidating an existing…

04 Aug 25

Vendor Audit & Approval

Vendor Audit & Approval Trust But Verify—The Agon Way Your supply chain is only as strong as your weakest vendor. Agon’s Vendor Audit & Approval services offer pharmaceutical companies a rigorous and repeatable method to qualify and monitor suppliers, contractors, and service providers. From API manufacturers to packaging vendors, we…

04 Aug 25

GMP System Setup

GMP System Setup Build the System Before the Batch A strong GMP system is the backbone of every compliant pharmaceutical operation. Agon’s GMP System Setup service helps new and expanding facilities establish end-to-end quality systems aligned with international standards. From SOP creation to document control, we lay the foundation for…

15 Oct 25

Facility Audit

Facility Audit Ensuring Compliance, Efficiency, and Operational Excellence Agon ME provides comprehensive Facility Audit services to help pharmaceutical and medical manufacturing sites meet GMP and international regulatory standards, including JFDA, SFDA, USFDA, EMA, and GCC. Our experts conduct detailed on-site evaluations covering facility design, equipment qualification, documentation systems, and production…

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15 Oct 25

Facility Equipment Design Review

Facility Equipment Design Review Ensuring Smart, Compliant, and Efficient Facility Design Agon Facility Equipment Design Review service ensures that every element of your facility — from layout to equipment selection — aligns with GMP principles, regulatory expectations, and operational efficiency goals. We help clients evaluate design concepts early in the…

15 Oct 25

Conceptual, Basic & Detailed Engineering

Conceptual, Basic & Detailed Engineering Transform Ideas into Compliant, Construction-Ready Pharmaceutical Facilities AGON delivers end-to-end engineering solutions covering concept development, preliminary engineering, and fully detailed designs — ensuring facilities are optimized for efficient operations, regulatory compliance, and long-term scalability. Our multidisciplinary engineering approach integrates cleanroom zoning, material–personnel flow, equipment and…

11 Jul 25

Management Representative Support

Management Representative Support End-to-End Project Oversight to Deliver Fully Compliant and Investment-Secure Pharma Facilitie AGON’s Management Representative Support assists pharmaceutical investors and companies throughout the complete facility establishment lifecycle — from feasibility study and market research to full project execution and final handover. Acting on behalf of the client, AGON…

11 Jul 25

Machine Qualification

Machine Qualification End-to-End IQ/OQ/PQ Support to Ensure Equipment Compliance and Production Readiness AGON provides complete qualification support for pharmaceutical equipment, ensuring every machine meets regulatory expectations, operates reliably, and is fully ready for GMP-compliant production. Our qualification process covers protocol development, execution, reporting, and documentation aligned with global regulatory standards.…

11 Jul 25

Utilities Qualification – HVAC & Water Systems

Utilities Qualification – HVAC & Water Systems Comprehensive Qualification of Critical Utilities for GMP-Compliant Pharmaceutical Operations AGON ensures that all critical utilities — including HVAC and pharmaceutical water systems — are fully qualified, reliable, and compliant with international regulatory standards. Our structured qualification process covers protocol development, execution, reporting, documentation,…

08 Nov 25

Market Expansion Strategy

Market Expansion Strategy Expanding Reach with Insight and Precision Agon ME’s Market Expansion Strategy services enable pharmaceutical and biotech companies to identify new opportunities, assess market potential, and enter regions strategically. We combine data-driven insights with regulatory expertise to help you grow confidently and sustainably. What We Deliver Market and…

08 Nov 25

Dossier

Dossier Reliable, CTD-Ready Files for Fast and Confident Product Registration AGON supports pharmaceutical companies in sourcing and acquiring high-quality, CTD-ready product dossiers that meet regional and international regulatory requirements. Our end-to-end coordination ensures clients receive complete, compliant technical files for product registration, technology transfer, and portfolio expansion — without the…

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