Validated once, and kept that way

Equipment, processes, and computerised systems only earn trust when the evidence behind them holds. We bring the engineering and validation expertise to design, qualify, and validate them, proportionate to risk, so your products move from development to routine production in a validated state.

What we offer Get in touch

What we offer

How we help your team

Practical, hands-on support, shaped around your products, your team, and the outcomes you need.

Design control and design transfer
We build and maintain design history files, design controls, and design transfer plans that meet EU MDR, IVDR, and FDA expectations. Documentation stays audit-ready as your product evolves.
Equipment and facility qualification
We plan and execute IQ, OQ, and PQ for equipment, utilities, and clean rooms. Protocols are clear, executed right first time, and easy to defend at inspection.
Process validation
We deliver risk-based process validation aligned to FDA, EMA, and ISO expectations. Effort stays proportionate to risk, so it lands where it matters.
Computerised system validation
We validate computerised systems in line with GAMP 5 and EU GMP Annex 11, with data integrity built in. Systems go live validated, and stay that way through change.
Risk management
We embed ISO 14971 and ICH Q9 risk management into design and validation decisions. Risk files stay live documents, not a one-off exercise.
Technology and site transfers
We plan and run technology transfers between sites and partners without losing control of quality. Risk is managed up front, so supply and compliance hold through the move.

How we work

Three ways to bring us in

Engineering and Validation can be delivered through any of our three models. You choose where ownership of the work sits.

01
Project staffing
Our specialists, embedded in your team.
Validation engineers, CSV specialists, and design control leads, embedded in your project team.
You direct the work, we bring the expertise
02
Managed services
We run it against your KPIs.
Managed services for periodic review, revalidation, and change control, keeping systems in a validated state.
You set the objectives, we run the day to day
03
Advisory and delivery
We define it, then build it with you.
Advisory and delivery for validation master plans and technology transfers, from strategy to executed protocols.
Shared, from roadmap through implementation