Pharmaceutical Automation Experts
We help pharmaceutical organizations implement, validate, and optimize Manufacturing Execution Systems and Distributed Control Systems — where compliance and operational performance are non-negotiable.
Start a Conversation →Who We Are
Sky Automation Solutions is an independent consulting firm specializing in Manufacturing Execution Systems (MES) and Distributed Control Systems (DCS) for regulated pharmaceutical environments. We help organizations improve operational efficiency, compliance, data integrity, and digital transformation initiatives.
We are not tied to any vendor. Our recommendations are based entirely on your process requirements, your team's capabilities, and your regulatory obligations. The consultant you meet on day one is the expert who delivers your project.
Our expertise spans greenfield projects, brownfield upgrades, multi-site rollouts, and continuous improvement programs — from API manufacturing to fill-finish and packaging.
What We Do
Senior-level consulting across the full MES and DCS lifecycle — scoped to your actual needs.
Requirements gathering, solution design, implementation support, recipe management, batch execution, and system optimization for pharma MES platforms.
Architecture design, migration projects, automation strategies, process control improvements, and full lifecycle support for distributed control systems.
CSV support, GMP compliance, GAMP 5 methodology, documentation review, testing strategies, and audit readiness — built into delivery, not bolted on after.
Integration between MES, DCS, ERP, LIMS, historians, and other manufacturing systems — with data integrity and interface control as first-class concerns.
Manufacturing data strategy, process digitization, KPI development, and operational excellence initiatives grounded in real process knowledge.
Technical leadership, project coordination, vendor management, commissioning, and startup support across the full project lifecycle.
Industry Focus
Our practice is built around environments where quality, compliance, and operational reliability are simultaneously critical.
API production, secondary manufacturing, fill-finish, and packaging operations where GMP compliance, data integrity, and electronic batch records are central requirements. We work across FDA, EMA, and ICH-regulated sites.
PLC, SCADA, and DCS projects for food & beverage, chemical, water treatment, and general industrial applications. We bring the same engineering discipline without the overhead of large system integrators.
Get In Touch
Whether you're scoping a multi-site MES rollout or a straightforward process control upgrade — we start with a conversation, not a proposal.
Romania · Available for remote and on-site engagements across Europe