Engineering, validation and intelligence for high-performance industries.
OneFit Projects is a multidisciplinary engineering house serving 24 industry verticals through 20 integrated capabilities. From feasibility and design to machines, inspection, qualification, AI and asset valuation, one accountable team owns the outcome.
Compliance by design
ISO, ASME, PED, FDA, GAMP 5 and IEC frameworks engineered in from day one, not audited in at the end.
What we do
Five practice groups. One engineering bench.
Most engineering vendors do one thing. Industrial problems rarely respect those boundaries. Our advisory, engineering, quality, digital and operations teams work as one, so design decisions, control constraints, compliance evidence and data plans get made together.
Industries
24 industry verticals, from regulated to heavy
Medical devices to mining, pharmaceuticals to power. Codes and regulators change between sectors; our standard of evidence does not.
Why industrial leaders choose OneFit Projects
Built to be the engineering partner you call first
Global OEMs, plant owners, EPC contractors, investors and institutions work with us because we combine the depth of a specialist with the breadth of a full-service house, and because we put our name on evidence, not opinions.
One accountable team
Mechanical, controls, software, AI, quality and valuation engineers on the same bench. No handoffs between vendors, no gaps.
Audit-ready evidence
Calculations, protocols, inspection records and reports written for regulators, notified bodies, lenders and insurers.
Regulated-industry discipline
Medical and pharmaceutical validation rigour applied wherever quality and safety are critical.
Measured outcomes
Cycle time, uptime, yield, energy, compliance findings. We agree the metrics up front and report against them.
How we deliver
Six stages from first conversation to lifetime support
Adapted to the size and complexity of your project. Never skipped.
Discover
Site walk-downs, stakeholder interviews and data review to fix the real problem, constraints and acceptance criteria before any design work begins.
Define
Requirement specifications, risk registers, budgets and schedules signed off with your team. Every downstream decision traces back to this baseline.
Design & simulate
Concept trade-offs, detailed engineering, FEA/CFD and digital models so decisions are made on evidence, not opinion.
Build & integrate
Fabrication management, machine build, controls, software and AI brought together as one system under one accountable team.
Validate & inspect
FAT/SAT, IQ/OQ/PQ, NDT, dimensional and functional inspection against the agreed criteria, with full traceable documentation.
Operate & improve
Handover, training, condition monitoring and continuous improvement programmes that keep assets performing for their whole life.
Case studies
Representative engagements
Anonymised under confidentiality agreements. Real problems, real methods, measured results.
Automated verification system for a Class II infusion pump line
Designed, built and qualified an end-of-line flow-accuracy and occlusion test system with 21 CFR Part 11 compliant data capture.
Commissioning and qualification of a greenfield oral solid dosage facility
Delivered the full CQV programme for a USFDA-targeted OSD plant, including 60+ equipment items, HVAC, utilities and BMS.
End-of-line test and leak-check cell for EV battery packs
Built a safety-rated EOL cell performing leak, insulation, HV functional and BMS communication tests at 90-second cycle time.
Standards & compliance
Codes, standards and regulations we engineer to
A selection of the frameworks our teams design, validate, inspect and document against. Compliance is designed in, not audited in.
About OneFit Projects
From mechanical design house to full-spectrum engineering partner
OneFit Projects began as a mechanical design, analysis and consultancy practice. As clients asked us to solve more of their problems, we added automation, special purpose machines, software, applied AI, validation, inspection and asset valuation. The principle never changed: the engineer who understands the physics should also understand the code, the regulation, the data and the commercial consequence.
For OEMs & manufacturers
Product development, machines, lines, automation, inspection and digital systems.
For plant owners
Integrity, reliability, validation, energy, modernisation and life extension.
For investors & lenders
Valuation, technical due diligence, lender's engineer and construction monitoring.
For institutions
Research partnerships, laboratories, training programmes and technology transfer.
Tell us about the problem you are trying to solve
Share scope, constraints and timeline. A senior engineer will respond with a practical path forward, whichever discipline it touches.







