Industry
Pharmaceutical & Biopharma Manufacturing
GMP facilities, equipment and systems qualified for global regulatory inspection.
Overview
How we work in pharmaceutical
We deliver engineering, automation, validation and digital systems for API, OSD, sterile, biologics and vaccine manufacturing. Our CQV and automation teams have delivered qualified equipment and computerised systems under USFDA, EMA, MHRA, WHO and CDSCO expectations.
Challenges we solve most often
- Qualifying equipment, utilities and computerised systems on aggressive project timelines
- Maintaining data integrity and 21 CFR Part 11 compliance across automation and IT systems
- Modernising legacy plants and control systems without regulatory disruption
- Reducing energy and water consumption in HVAC-intensive facilities
What we deliver
Engineering, validation and digital solutions for pharmaceutical
- Validation master planning and full CQV execution for equipment, utilities and facilities
- GAMP 5 computerised system validation for PLC, SCADA, BMS, MES and LIMS
- Cleanroom HVAC design, airflow CFD and ISO 14644 qualification
- Purified water, WFI, clean steam and compressed air system engineering
- Process equipment and packaging line design, automation and serialisation integration
- Energy audits and decarbonisation of pharmaceutical utilities
Capabilities applied
Disciplines we bring to pharmaceutical programmes
Validation & Qualification
Commissioning, qualification and validation that regulators accept the first time.
View capabilityAutomation & Controls
Control systems designed, programmed, tested and commissioned as one responsibility.
View capabilityRegulatory & Compliance
Engineering that clears CE, FDA, PED, ASME and national approvals without rework.
View capabilityDesign & Development
From a blank sheet to production-ready drawings, with manufacturability built in.
View capabilityEnergy & Sustainability
Cut energy, water and carbon with engineering that pays back.
View capabilitySoftware Engineering
Industrial-grade software that connects the shop floor to the boardroom.
View capabilityProject Management & EPCM
Complex industrial projects delivered on scope, schedule and budget.
View capabilityDigital Twin & IIoT
A live, calibrated model of your plant that you can plan, test and optimise against.
View capabilityCodes, standards and regulations
Frameworks we engineer and document to in this sector
Compliance is designed in from the first specification, not audited in at the end.
- EU GMP Annex 1, 11, 15
- 21 CFR 210/211
- 21 CFR Part 11
- GAMP 5
- ISPE Baseline Guides
- ISO 14644
- WHO TRS 961
- Schedule M
Representative engagements
Pharmaceutical case studies
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.
CFD-led cleanroom airflow design and qualification for an aseptic filling suite
Used CFD to design unidirectional airflow and pressure cascades for a Grade A/B suite, then qualified the installed system.
Other industries
Explore adjacent sectors
Planning a pharmaceutical project?
Our sector engineers will review your scope and come back with options, risks and a realistic plan, at no cost for the first conversation.