A selection of engagements that illustrate how we work, from facility design through to GMP compliance and qualification. Client identities are withheld under confidentiality; scope and outcomes are as delivered across the MENA region.
Acted as management representative for a leading MENA pharmaceutical manufacturer, owning the GMP compliance interface with regulators and holding the site in a continuous state of inspection readiness.
Assessed an operating facility against current GMP expectations across building, utilities, systems and documentation, then translated the findings into a prioritised, risk-based remediation roadmap the client could execute with confidence.
Reviewed a new facility design against GMP requirements before construction, resolving layout, flow and classification issues on paper — where they cost little to correct — rather than on site or at audit.
Mapped and qualified temperature- and humidity-controlled assets — cold stores, warehouses and stability chambers — with risk-based scoping and 21 CFR Part 11-compliant data, evidencing full GSDP and GMP conformance.
Engineered a new oral solid dosage facility from conceptual layout through detailed design, developing the GMP room layout, personnel and material flows, HVAC and pressure-cascade scheme and clean utilities — all coordinated in a single 3D model and issued as a construction-ready, inspection-aligned package.
From the first concept sketch to a qualified, inspection-ready plant, Agon partners with pharmaceutical manufacturers to engineer facilities that meet the highest international standards. We would welcome the conversation.
