Site selection, GMP-compliant facility design, equipment qualification, validation, and tech transfer — built and handed over ready to operate.
Why teams choose us
From greenfield site selection to production hand-off — every milestone owned.
Location analysis, regulatory zone confirmation, utilities and logistics audit.
Cleanroom classifications, material/personnel flows, HVAC and utility design.
URS development, vendor selection, purchase liaison, factory acceptance testing.
Installation, operational, and performance qualification protocols and execution.
Three-batch validation, cleaning validation, stability protocols.
Process documentation, operator training, batch record templates.
Six phases with hard milestones — your build stays on track.
Cost model, location options, regulatory zone analysis, ROI projection.
Architectural and engineering design, classified zones, utility plans.
URS, vendor selection, purchase orders, manufacturing oversight, FAT.
Equipment installation, site acceptance, utility commissioning.
IQ/OQ/PQ protocols, process validation, cleaning validation.
Operator training, SOP rollout, supervised first commercial batch.
Facility design that meets ISO 14644, EU GMP Annex 1, and US 21 CFR Part 210/211.
“Our facility was commissioned smoothly and was audit-ready, with validation handled end to end.”
Pre-vetted equipment suppliers — better prices, faster delivery, reliable quality.
From small disposables to high-volume IVD reagent manufacturing.
Dedicated IQ/OQ/PQ team with deep equipment qualification experience.
Facility commissioned, audit-ready
A company establishing a new IVD manufacturing facility faced GMP-compliance and workflow challenges. We designed a GMP-compliant layout, planned cleanroom classifications and workflows, and supported equipment qualification and validation.
GMP-compliant
Facility layout
Qualified
Equipment & validation
Audit-ready
Infrastructure
Commissioned
Production facility
Quick answers about scope, timelines, and how this engagement runs.
Ask us directlyNo — we also retrofit existing facilities to GMP standards, expand capacity in operational plants, and remediate facilities that have failed audits.
Highly device-dependent. A small Class A reagent facility sits at the lower end, while complex parenteral or implantable facilities are significantly higher. We share a detailed cost model during the feasibility phase.
Yes — for design, qualification, and validation phases. Equipment procurement is pass-through with a managed-services fee.
Yes — we set up CMO operations including dual-tenant facilities with appropriate segregation and quality systems.
We offer annual retainers covering SOP updates, training, mock audits, and CAPA management.
Tell us your device, capacity, and target launch date. We’ll send a feasibility brief within a week.