Pharmaceutical manufacturing is unforgiving. A single failed EU GMP inspection can halt production, trigger recalls, and cost years of remediation. We build EPCM projects where regulatory compliance isn't a final check — it's the foundation everything is designed around.
Most pharmaceutical inspection findings trace back to engineering decisions made earlier in the project — not to operational failures. We understand where those risks sit, and we design them out early.
URS documents that don't trace through to FAT protocols. IQ executed without reference to approved DS. OQ parameters that were never rationally derived from the FDS. We structure the entire V-model from day one so every qualification document is evidence of something that was actually tested.
ISO 14644 Grade A/B/C/D boundaries that work on paper but fail under operational pressure. Airlock cascades that don't cascade correctly. Gowning routes that create contamination vectors. We design cleanrooms for how they will actually be operated — with the operators in the design session, not just the engineers.
Software systems installed by suppliers who don't understand GAMP 5. User requirements defined after the system is already configured. CSV documentation assembled retrospectively. We validate computer systems (SCADA, DCS, MES, LIMS, ERP) prospectively — from URS to periodic review.
Factory tests run at the vendor's site that generate no IQ evidence. SAT protocols written after FAT has been "completed." We write FAT protocols that serve double duty as OQ evidence — reducing total test time by weeks and eliminating the need to rebuild the documentation package for inspectors.
Facilities that weren't designed with change control in mind cost significantly more to manage over their lifetime. We design change-managed systems — including document hierarchies, drawing revision controls, and as-built capture — as part of the initial engineering scope.
Equipment purchased without a DQ. Suppliers selected without GMP capability assessment. Delivery timelines that don't account for vendor qualification or equipment testing. We manage pharmaceutical procurement with the qualification lifecycle in view from the first specification.
We cover the full project lifecycle for pharmaceutical and biotech facilities — from site feasibility through to final qualification and handover. Every deliverable is structured around the regulatory requirements of your specific product and market.
Process plant and cleanroom design for sterile, oral solid dose, biological, and API manufacturing. EU GMP and FDA-compliant by design, not by review. HVAC, utilities, and material flow engineered to Grade requirements.
VMP development, DQ, IQ, OQ, PQ protocol writing and execution support. V-model structured from URS to PQ summary. Independent review and witness services for all qualification stages.
FAT protocol development aligned with FDS and DS. Independent technical witness at vendor sites. SAT programme coordination. Punch list management and defect resolution through to GMP release.
CSV for SCADA, DCS, MES, LIMS, ERP, and lab systems. Category 4 and 5 systems under GAMP 5. EU Annex 11 and FDA 21 CFR Part 11 compliance. Periodic review programmes.
On-site EPCM management for cleanroom construction, facility upgrades, and process installation. GMP-aware site management — your contracts, our oversight, your regulatory accountability protected.
Our fixed-scope entry product for pharma clients. We review your qualification programme before it starts — identifying gaps, clarifying the V-model structure, and defining the scope. Delivered in 5 working days. Learn more →
Whether you're a CDMO running continuous qualification programmes, a mid-size manufacturer upgrading facilities, or a scale-up commissioning your first GMP suite — our approach adapts to your regulatory context and project scale.
Ongoing qualification, new suite fit-outs, CSV for multi-product platforms
Facility upgrades, EU GMP compliance, solid dose and liquid manufacturing
First GMP facility, VMP development, cleanroom engineering from scratch
Containment engineering, ATEX, cGMP API process plant, HAZOP support
Three aseptic filling suites. Full V-model qualification. FAT structured to generate IQ evidence directly. EU GMP inspection passed first attempt.
Warehouse-to-GMP conversion. ISO 14644-1 Class D cleanrooms. GAMP 5 validated MES. IGJ inspection passed with zero findings.
Lab-to-GMP transition in under 18 months. Engineering design, cleanroom construction, full IQ/OQ qualification for Grade C and B suites.
The V-model isn't just a regulatory requirement — it's a project management tool. When it's done correctly, every qualification protocol is the mirror image of a design specification. Nothing is tested without a requirement. Nothing passes without traceability.
| URS | → | validates | → | PQ |
| FDS | → | validates | → | OQ |
| DS | → | validates | → | IQ |
| FAT → SAT | ||||
C2Improve writes FAT and SAT protocols that are directly traceable to the FDS and DS. This means FAT evidence is IQ/OQ evidence — tested once, not twice. For a typical equipment qualification, this saves 4–8 weeks of repeat testing and documentation.