What we do
Four areas, one thread: keeping a technical project on track from the first concept sketch to the documents that have to hold up in an audit.
What we work on
Fill & finish, machine by machine: washers and depyrogenation tunnels, filling and closing machines, freeze dryers, inspection and vision systems, autoclaves, and isolators — including standalone units. PUPSIT arrangements and the systems around them. We also work on laboratory equipment, from selecting the supplier to getting the data out of it.
Consulting & Advisory
We sit on your side of the table, from the first supplier conversation to handover:
- Supplier Selection & Tendering. Specifying the requirement, finding suppliers and comparing what comes back.
- Technical Contracts. Reviewing scope, specifications and acceptance criteria before signature.
- Project & Vendor Management. Running the vendor through design, FAT, SAT and delivery.
Design Services and Risk Analysis
The engineering thread, from concept through to qualification:
- Conceptual, Basic & Detailed Design. Comprehensive, functional designs — and the review and verification that keeps them honest.
- Recipe Systems & Parameters. Mapping recipes and parameters so the plant can be configured, and so the configuration holds up under GMP.
- Risk Analysis. Alarm system classification and process risk analysis.
- Test & Qualification. FAT, SAT and IQ/OQ — we write qualification protocols ourselves, and we review the ones your supplier delivers.
Manufacturing Intelligence
Getting the right data out of the plant, and something useful out of the data:
- User Journeys & Use Cases. What operators and process people actually need to see.
- Data Scope & Tag Selection. Deciding which process data is worth collecting in the first place.
- Data Storage & Integrity. How data is stored, retained and kept auditable.
- Statistical Analysis. Process improvements from the data you already have.
Courses & Training
Training for the people who have to use the documents afterwards:
- Core Courses. Our own programme, for specialists, technicians and process support.
- Bespoke Courses. Developed with your department, around your own machines and documents.
How the work is priced
Time and Materials
Work that follows the project — vendor follow-up, design review, troubleshooting and support on site — is invoiced by the time spent, so the scope can move with the project.
Fixed Price
Work with a defined scope and deliverable — a specification, a risk analysis, a qualification protocol or a course — is quoted at a fixed price before it starts.