Cleanroom wall panel construction in progress

Delivery Model

One contract. One point of accountability.

Nine phases from feasibility to regulatory readiness, with the documentation workstream running alongside the engineering workstream rather than behind it.

01

Phased Delivery

How a project actually runs.

  1. Feasibility and concept design

    Product range, target market and site are turned into a block layout and a capacity model, so the commercial case and the building are tested against each other before money is committed.

  2. Detailed engineering

    GMP layout and flow, civil and structural, MEP, HVAC and utilities are taken through to issued-for-construction drawings and user requirement specifications.

  3. Procurement and manufacture

    Vendors are qualified, equipment is contracted for by us as principal, and manufacture is tracked against the construction programme.

  4. Shipment and site mobilisation

    Factory acceptance testing before dispatch, then packing, export documentation, shipping and delivery to site, with the site prepared to receive it.

  5. Installation and commissioning

    Mechanical installation, orbital-welded hygienic pipework, utility tie-ins, and site acceptance testing once equipment is in position.

  6. Qualification and validation

    IQ, OQ and PQ executed and documented, alongside utility qualification, process validation and cleaning validation.

  7. Trial batches and technology transfer

    Formulation recipes established, trial batches run, and process knowledge transferred to the client's own production team.

  8. Training and handover

    Operators, technicians and quality staff trained to run the plant, and the facility handed over with its documentation set complete.

  9. Regulatory readiness

    Documentation structured for inspection and, where the scope includes it, product registration dossiers compiled for the target market.

Parallel Tracks

Documentation does not wait for the building.

On most projects the quality documentation is assembled after construction, which is why so many finished plants sit idle waiting to be licensed. We run the two workstreams together from the first week.

Parallel engineering and documentation workstreams Two lanes run left to right across the project from day one to handover. The upper engineering lane runs concept and layout, detailed engineering, installation and commissioning. The lower documentation lane runs in parallel from the same start point: user requirement specifications, standard operating procedures and quality management system build, IQ OQ PQ protocols, and validation and dossier work. Both lanes converge at handover, described as a qualified plant delivered with its documentation set complete. DAY ONE HANDOVER ENGINEERING WORKSTREAM Concept & layout Detailed engineering Installation Commissioning DOCUMENTATION WORKSTREAM URS & specifications SOPs & QMS build IQ / OQ / PQ protocols Validation & dossier Both lanes converge at handover: a qualified plant, delivered with its documentation set already complete.
02

Engagement Models

Four ways to work with us.

  • 01

    Full turnkey execution

    Design through to a qualified, documented, operating plant under one contract and one point of accountability.

  • 02

    Machinery supply only

    Specification, supply, installation and commissioning of equipment and utility systems, where the client holds the balance of the project.

  • 03

    Post-commissioning management contract

    Continued involvement after handover, supporting the operation of the plant while the client's own team builds depth.

  • 04

    Raw and packing material supply

    Ongoing supply of raw materials and packing materials to plants in production.

Planning a pharmaceutical facility?

Tell us the dosage platforms you are considering, the market you are registering in and the status of your site. We will tell you what the project actually involves.

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