Pharmaceutical IT & Validation Consulting · Dublin, Ireland

Turning Complex
Pharma Projects Into
Compliant Reality

Trusted partner for GMP capital project delivery, CSV/CSA validation, IT/OT integration, Data Integrity programmes, and AI enablement — across Ireland's leading pharmaceutical manufacturers.

Our ServicesStart a Conversation
10+
Years in GMP-Regulated Environments
€7M+
Data Integrity Programmes Delivered
€1M+
Savings Through Strategic Optimisation
0
Critical Regulatory Findings During Supported Inspections
About Dreamss Infotech Ltd

Where Regulatory Rigour Meets Delivery Excellence

Dreamss Infotech Ltd is a specialist consulting practice built on over a decade of hands-on experience delivering complex IT, OT, and validation programmes within Ireland's most demanding pharmaceutical manufacturing environments.

We work with pharmaceutical organisations — from greenfield builds to brownfield remediation — to deliver capital projects, qualification programmes, and Data Integrity initiatives that are compliant, on time, and built to withstand regulatory scrutiny.

Our founder brings direct experience from global pharmaceutical organisations including Regeneron, MSD, Bristol Myers Squibb, Alexion/AstraZeneca, and Abbott, with a track record of leading multi-disciplinary teams across IT, QA, Validation, Manufacturing, and Engineering.

🏭
Greenfield & Brownfield Experience
Full site lifecycle — from new-build implementation to live-site remediation and decommissioning planning.
📋
Audit-Ready Delivery
Zero critical regulatory findings across multiple supported inspections. We build compliance in from day one.
🔗
IT/OT Integration Specialists
Deep expertise across MES, LIMS, SCADA, DCS, ERP, and Data Historian environments — ISA 95 Level 2–4.
🌍
Global Client Network
Delivered across multi-site, multi-timezone programmes for some of the world's leading pharmaceutical organisations.
What We Do

Consulting Services

End-to-end expertise across the full pharmaceutical IT and validation lifecycle — from capital project initiation to go-live and beyond.

🏗️
Capital Project Management
Full lifecycle delivery of pharmaceutical capital projects — managing scope, budget, schedule, and multi-disciplinary teams from initiation through commissioning and go-live.
GMPBrownfieldGreenfieldEHS
✅
CSV / CSA & Validation
Risk-based computer system validation and computer software assurance programmes. Full SDLC documentation — URS, RS, CS, RTM, IQ, OQ, PQ — authored, reviewed, and approved to regulatory standard.
GAMP 521 CFR Part 11ALCOA+
🔬
Lab Systems & Instrument Qualification
Implementation and qualification of laboratory systems and analytical instruments. IOQ protocol authoring, review, and hands-on execution for LIMS, Empower, LabX, and analytical platforms.
LIMSEmpowerLabXIOQ
🛡️
Data Integrity Remediation
Multi-site Data Integrity assessment and remediation across enterprise applications, lab systems, automation, and IT infrastructure — restoring compliance posture and audit readiness.
ALCOA+Data IntegrityRemediation
⚙️
IT / OT Integration
Enterprise IT/OT integration across MES, SCADA, DCS, PLC, ERP, and Data Historian environments. ISA 95 Level 2–4 architecture design, implementation, and validation.
MESSCADAISA 95DCS
📊
IT Service & Operations
Post-go-live IT operations management, application lifecycle ownership, change control governance, and regulatory inspection support — ensuring sustained compliance after delivery.
ITILServiceNowITSMChange Control
🤖
AI Consulting for Life Sciences
Pragmatic AI strategy and adoption roadmaps for GxP-regulated environments. We help pharmaceutical teams identify high-value use cases — from manufacturing analytics to QA review automation — and design GAMP-aligned governance, validation, and risk frameworks for AI/ML systems.
GAMP 5 AIUse-Case DiscoveryAI GovernanceModel Risk
🧭
AI Product Management
End-to-end product leadership for AI initiatives: discovery, problem framing, dataset readiness, success metrics, and delivery. We translate scientific and operational needs into prioritised AI product roadmaps, manage cross-functional teams (Data, MLOps, QA, SMEs), and drive measurable outcomes through every release.
DiscoveryRoadmappingMLOpsKPIs
🧠
AI Build & Enablement
Hands-on support to design, build, and validate AI solutions — LLM-powered assistants, RAG over SOPs and validation records, predictive quality, and intelligent document processing. We work alongside your engineers to ship production-grade systems with the documentation, traceability, and controls auditors expect.
LLMsRAGValidationData Integrity
Technical Depth

Expertise

Deep domain knowledge across the full pharmaceutical IT and validation technology stack.

CSV / CSA & SDLC Execution
GAMP 5 · 21 CFR Part 11 · ERES · ALCOA+ · Risk-Based Approach
Laboratory Systems
LIMS · LabX · Empower · IOQ · Analytical Instrument Qualification
Capital Project Delivery
End-to-End Lifecycle · Budget & Schedule · Multi-Disciplinary Teams
IT / OT Integration
MES · SCADA · DCS · PLC · Data Historian · ISA 95 L2–4
Data Integrity & Compliance
ALCOA+ · USP <1058> · Audit Readiness · Regulatory Inspection Support
Enterprise Applications
ServiceNow · SAP ERP · QMS · ITSM · Change Control
GMP & Regulatory Frameworks
cGxP · GMP · SOP Compliance · Change Control · SDLC Documentation
Project & Delivery Methodology
Agile · Scrum · Waterfall · Hybrid · JIRA · Smartsheet · MS Project
Impact

Measurable Outcomes

Delivery that is quantified, not just qualified.

€7M+
Data Integrity programmes delivered across IT, OT, Automation, and Lab Systems
€1M+
Cost savings achieved through strategic planning and resource optimisation
0
Critical regulatory findings during supported GMP inspections
5+
Global pharmaceutical organisations served across greenfield and brownfield environments
Get In Touch

Ready to Talk?

Whether you have an upcoming capital project, a validation programme that needs expert oversight, or a Data Integrity challenge that needs resolving — we'd welcome a conversation.

We work on contract and consulting basis with pharmaceutical organisations across Ireland and internationally. Response within one business day.

Available for new engagements — Dublin & Remote
Your details will not be shared with any third parties.
✓ Thank you — we'll be in touch within one business day.