Pharmaceutical IT consultancy
20 years of hands-on IT experience within pharmaceutical manufacturing — not theoretical compliance advice, but practical guidance from people who've worked on the factory floor and understand what it actually takes to get it right.
We've lived it — not just studied it
The difference between knowing the regulations and knowing how to comply with them in practice is enormous. We bridge that gap.
Operational experience
We've worked within IT at large-scale pharmaceutical manufacturing facilities — managing the systems that support production, quality, and supply chain. We understand the pressures, the constraints, and the reality of keeping a regulated site running.
Practical compliance
We're not quality consultants who understand IT in theory. We're IT professionals who understand regulatory compliance in practice — and know how to achieve it without grinding operations to a halt.
Always current
Regulations evolve. We constantly stay up to date with the latest guidance — from GAMP5 second edition to evolving EU GMP Annex 11 expectations — so you don't have to.
Experience across markets and regulatory frameworks
We've delivered pharma IT consultancy across the globe — working within different regulatory environments and understanding the nuances that come with each. Whether it's an EU GMP-regulated facility in Germany or a manufacturing site in the Middle East, we adapt to the local context while maintaining the rigour that regulators expect.
How we help
From proactive risk identification to emergency remediation — we cover the full spectrum of pharma IT compliance.
Risk identification & gap analysis
We help organisations identify where they're exposed from an IT compliance perspective — mapping systems against regulatory requirements and highlighting the gaps before they become findings.
IT compliance audit
A thorough internal audit of your IT landscape against GxP requirements. We assess your systems, processes, and documentation — then provide a clear, prioritised remediation plan to close the gaps before they become a regulatory problem.
Best practice guidance
Practical advice on how to structure your IT operations to achieve and maintain compliance. Not a theoretical framework — actionable guidance you can implement immediately, grounded in what actually works on site.
Remediation support
Already discovered regulatory gaps — through your own audit or an inspection? We parachute in to provide practical, expert advice and hands-on help to close out findings quickly and effectively.
Frameworks & standards we work with
When to call us
"We want to get ahead of it"
You know compliance matters but aren't sure where you stand. We come in, audit your IT landscape, identify the risks, and build a prioritised plan to close the gaps — before an inspector finds them for you.
"We've found gaps and need help now"
An audit or inspection has uncovered regulatory findings. You need experienced people who can hit the ground running — understand the findings, assess the impact, and help you remediate quickly with practical, defensible solutions.
Need pharma IT expertise?
Whether you're preparing for an inspection or responding to one — we can help.