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GxP Services for European Life Sciences

Every service we deliver
runs under one quality system.

GxP-Cloud provides qualified cloud infrastructure, managed platform services, statistical computing, object storage, disaster recovery, and quality compliance services — all operated under a single GxP Quality Management System reviewed by over 100 auditors. You focus on science. We handle IT and compliance.

The GxP-Cloud difference
One QMSgoverns every service we deliver
60–95%of your GxP burden assumed
100+auditors have reviewed our quality system
Day oneROI from the moment you go live
Infrastructure and platform

Qualified infrastructure. Managed platform. Built for life sciences from the ground up.

Our core infrastructure and platform services form the qualified foundation on which every regulated application runs. Every layer is managed under QA oversight, documented to IQ/OQ standards, and audit-ready at all times.

Quality and compliance

Quality services for every stage of the regulated lifecycle.

Beyond the quality infrastructure that underpins our hosting services, we provide standalone quality and compliance services. From pre-commercial QMS setup to inspection readiness preparation — practical, sustainable, built to last.

Our quality system

Quality is not a feature. It is the foundation.

GxP-Cloud was a quality company before it was a hosting company. Our Quality Management System was established before the first data centre went live. That sequence has never changed.

Every service we deliver — infrastructure, platform, storage, analytics, disaster recovery — operates under a single GxP QMS. Our independent Quality team oversees all engineering activities. Our audit trail is always current. Our documentation is always ready.

Independent QA team separate from engineering
Formal change control for every infrastructure and platform change
SOP-governed operations from installation through lifecycle
Our QA team attends regulatory inspections alongside you
Regulatory update monitoring — we track what inspectors examine
100+
Auditors have reviewed and approved our Quality Management System across EMA, MHRA, and FDA regulated environments. That institutional knowledge is embedded in every service we deliver.
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Who we serve

Purpose-built for every stage of the life sciences journey.

From pre-commercial biotech entering the GxP world for the first time to global pharma scaling compliant infrastructure across regions — our platform and services adapt to where you are and where you are going.

Sponsors (pre-commercial)

Enter the GxP world cost-effectively with Quality System as a Service. Start at the finish line with a mature, comprehensive GxP infrastructure from Phase II through regulatory readiness.

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Sponsors (post-launch)

Scale GxP systems efficiently with hybrid-cloud infrastructure that reduces cost as you grow. Keep your compliance posture strong through commercialisation and post-marketing.

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GxP SaaS providers

Pre-qualified, audit-ready infrastructure that accelerates customer deployments and shortens sales cycles. Pre-sales auditability and RFP support for regulated software vendors.

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CROs, CMOs and CDMOs

Partner with the GxP cloud leader your clients already trust. Free up resources for high-impact activities while infrastructure compliance is managed by specialists.

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Medical device companies

Comprehensive GxP-compliant infrastructure for medical device organisations — from secure document management and FDA cybersecurity submissions to validated cloud infrastructure and audit defence.

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Clinical data and biostatistics teams

GxP-qualified statistical computing environments for SAS, Posit, Python, and the full regulated analytics stack. Your tools, your workflow, our qualified infrastructure underneath them.

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You are already going to pay about the same for public cloud. Why not have us do the work?

Building a GxP-compliant environment on public cloud requires your team to own infrastructure qualification, change control, compliance documentation, audit defence, and ongoing quality oversight. That is not what you hired them to do. GxP-Cloud assumes 60 to 95 percent of that burden from day one.

Talk to us about your environment
Who carries the GxP burden
GxP-CloudYou own 5–40%
We handle 60–95%
Application config, UAT, and business decisions remain with you
Public cloud (AWS / Azure / GCP)You own 97%
Infrastructure, QMS, qualification, audits — all on your team
Do it yourselfYou own 100%
Every layer: your team, your budget, your risk

Every service. EU data centres. EMA-first compliance.

GxP-Cloud is built for the European regulatory environment. EMA Annex 11 leads in every service we deliver. GDPR-compliant data residency is standard. EU contracting through Validated Cloud BV, Hoofddorp, Netherlands.

EMA Annex 11 — primary framework in all EU services
MHRA post-Brexit guidance addressed specifically
GDPR-compliant EU data residency as standard
EU data centres in Amsterdam and Dublin
Contract through Validated Cloud BV, Netherlands
21 CFR Part 11, ISO 27001, GAMP 5, HIPAA aligned

Not sure which service is right for your situation?

Most engagements start with a 30-minute conversation. We listen, assess your situation, and outline what GxP-Cloud looks like for your specific environment and regulatory obligations. No commitment required.

EU +31 20 399 1018  •  US +1 617 849 8650  •  info01@validatedcloud.com